e1905 Clinical Trial

[flowerlady]

Hi Everyone!

Does anyone participate in the e1905 clinical trial or have any prior experience with it? Would love some feedback please.

Sunny Regards,
Flowerlady

[Marrowforums]

e1905 is the trial ID number for a trial named Azacitidine With or Without MS-275 in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia.

Azacitidine is Vidaza, used in treatment of MDS.

MS-275 inhibits HDACs (histone deacetylases). Since HDACs regulate gene transcription, HDAC inhibitors have the potential to reduce the production of targeted (disease) cells.

This trial will study the safety and efficacy of MS-275 when given in conjunction with Vidaza. The study details can be found at clinicaltrials.gov (http://clinicaltrials.gov/ct2/show/NCT00313586) and at the two centers running the trial: Johns Hopkins (http://www.hopkinskimmelcancercenter.org/clinicaltrials/protocol2.cfm?pID=E1905) and Stanford (http://med.stanford.edu/clinicaltrials/detail.do?studyId=544). A previous study (http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1852211) found MS-275 to have potential benefits for MDS treatment and therefore to be worth further study.

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My husband just signed on for this clinical trial through Emory. Not sure if he'll be in the group that receives the MS-275 yet, but will know by Wed. Please keep my husband Ron in your prayers.

[Vera W]

I was offered this trial but decided it was too far to drive (106 miles) since I could get the azacitidine close to home. I was also told that it could hinder my transplant process for quite some time(insurance issues) so I opted out. But even if your husband just gets the azacitidine I have to say that the results have been remarkable for me. My hemoglobin went from 10.2 and has been holding strong at 13.8 and I feel so much better. Initially his counts will drop but it is wonderful as they start coming up. Tell him to drink lots of water it is very dehydrating.Best wishes!

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Vera,
Thank you for the response! you're right, 106 miles is quite the drive... we're lucky that we're so much closer. I'm so happy to hear the encouring news that you're doing so much better with the azacitidine. Are you receiving the injections too? And, what are your cycles? And, when did you start feeling better?

Thanks, Cindy

[Vera W]

Hi Cindy, barely a week passed after my DX last Oct and I was receiving my first Vidaza injection. I started with 160MG, Half a dose on each side of my stomach for 7 days. November was rough, it is not unusual for your counts to go down before they go up. ALWAYS while I am receiving the drug my counts are all normal.It cycles down to the nadir (LOW) point after about two weeks. Right before Thanksgiving my WBC was 1.9 and my neutrophils 14. The doctor was worried that I would get sick but I did fine and even though I was very low I was never neutrophenic. I didn't have to have any blood boosters but my doc wanted the Vidaza to follow it's natural course. He was pleased because it was doing it's job. I was very tired and had to take things a little at a time. My December injections were a little late as we were waiting for my counts to come back up. He wanted the neutrophils above 20%. He lowered my dose to 130mg for 2 cycles. in February I went back to my normal dose. Again for about two weeks my counts are remarkable, My wbc was 10 and neuts were 65% in the beginning, they still cycle down but not as low. Last week (3rd week) I was 4.9 my neutrophils are about 40% and seem to like to stay there. My Hemo has been normal since Febuary and so are my reds that alone gives me more energy. I had my BMB after my 4th cycle and my blasts went from 12% to 2%. I will be going into my transplant in optimal condition. I had on site reactions to the Vidaza..Red, hot and itchy and some hematomas. It doesn't happen with everyone. It is a small price to pay for my life. My liver enzymes also shoot up but always come back down. I strongly suggest a daily laxative like Milk of Magnesia for your husband even if he experiences some diarrhea at first. He will have ups and downs, take it a day at a time and make sure he rests as his body asks him to! Since my transplant has been moved forward I will be starting round six of Vidaza today and will be thinking of your husband. Take care, Vera

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Thank you Vera! I appreciate the details! And suggestions! We're both very anxious, but, so looking forward to progress so he can start feeling better and we can get to a bit of normalcy again... I miss his smile... he's been feeling pretty bad lately. But - chin up! He's been diagnosed, we have a plan, and we start on Wed or Thurs... we'll find out Wed this week. :-) I will also keep you in my prayers...

Hugs, Cindy

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Ron had his pre-clinical trial BMB Friday (3/27/09) and was extremely run down afterwards. He should start Vidaza treatment at least tomorrow afternoon, or Thurs. (We find out tomorrow, as there were some preliminary tests that had to be accomplished before we start the clinical trial.

He had a bad night last night, temp 102.9F. He felt so bad. We called Emory and talked with the on-call Doctor for the Oncology Dept. He cautioned us to keep what he called a "Short Fuse".... meaning, don't try to wait it out. He knew we had an appt on Wed (4/01/09) and that Ron didn't really want to go to the ER. He discussed other symptoms, etc... very thorough. He then said to take one dose of Tylenol & we had already told him we were applying ice to Ron's back of his neck... seems to really bring his temp down easily. But, said, if it went any higher to come into the ER immediately, but, if it started going down, monitor it closely.

I checked him throughout the evening. It finally went down to 98.8F. He's been running low-grade temps daily since dx Feb'09, but, normally never goes over 100.5F He has nightly sweats from the neck up every single night though. He gets really clamy and has difficulty sleeping....

I've been talking him through "Visualizing" good health and reading him scriptures about "God's Medicine" and healing.... Now, tomorrow, along with God's Medicine, we start Vidaza.....

I appreciate this Forum, you all are wonderful!

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My Husband, Ron, started this clinical trial April 1, 2009. He's on a 10-day cycle of Vidaza, by injection - 105 is the dosage. He was in the group that would not receive the MS-275. The first cycle was a tough one for Ron. He was nauseated and constipated. He kept saying he felt "weird". He was very tired and run down and his legs ached. He developed mouth sores for just a few days and he used a mouthwash called BIOTENE. Seemed to work good for him. He's continued using the Biotene mouthwash and toothpaste regularly. He also took off work during his 10 days cycle of Chemo and during the 18 days before his next cycle, he tried to work fulltime but just ran himself down. He finally agreed he should only work half days and this seems to have helped him tremendously. During Cycle #1, Ron needed a RBC transfusion.


At the beginning of Cycle #2, Ron's WBCs were low - at 1200 and Neutraphils are down to only 15%. One week prior, they were at 33%, and one week prior to that, they were at 65%. So, they are dropping right now. The Doctor changed Ron's antibiotic. He takes it daily. Amazingly, Ron's platelets, had been running between 89,000 and 112,000. Now they're at 240,000. So those have increased.

Now, on with Cycle # 2.... so far, it's been like night and day compared to Cycle #1. Ron's spirits have also been lifted tremendously. The amazing thing is, although he's still tiring easily, he's aleady feeling somewhat better. He hasn't had any mouth sores, but, as mentioned earlier, he's continued to use the Biotene mouthwash and toothpaste as a preventative maintenance. He also uses a toothbrush steralizer. The 2nd and 3rd day of chemo (Vidaza), Ron's left bottom teeth hurt. He said they felt like they were going to explode.? I gave him some regular strength Tylenol and told him to ensure he drinks plenty of water... He only had 2 days of this type pain. He saw his doctor today and the doctor said, after cycle #3, Ron should start feeling even better... Right now, with cycle# 2, once again, Ron has constipation.

We keep praying... and trying to do the right things.... we keep reading, and learning....and try to apply what we learn to help improve Ron's condition...

Hugs & Prayers to all of you! Cindy

[Birgitta-A]

Hi Cindy,
Good that Ron seems to respond :)!
Kind regards
Birgitta-A

[Vera W]

I use milk of magnesia every night before bed after literally screaming through the first cycle and being scolded for using an anemia! You know infection worries! I keep water by my bed stand and Make myself drink whenever I think of it. Stools are watery but it is better than being impacted!! Ron has a major battle going on in his body..I never want to give it up but rest is always the best remedy!! Glad things are progressing better!

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Vera,
Thanks for the reminder. I did tell Ron to take Milk of Magnesia and he did... but, he wasn't getting relief quick enough. Finally, the doctor prescribed something that works - a liquid he takes when constipated. Prune juice helps him, if he can remember to take it regularily. And, I agree with lots of water and Rest....

Sincerely, Cindy

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Birgitta,

Thanks for the reply... I know I've been a stranger lately.... but, things are looking up. We've also met another couple.. the husband is on the same clinical trial and he did receive the MS-275. He gets the same dosage of Vidaza as my husband, Ron, but, he's also getting the MS-275. He said he started feeling better cycle #4. He is in really good spirits, and it's funny because he doesn't have fat on his body, so he's gotten creative with the injections. He's asked "Where else" can he get the injections? So, he alternates, telling the nurses where to inject him. During a 10-Day cycle, he gets them in his stomach, inner-upper thigh, and upper arm (inside, where the fat tissue is). He use to be a marathon runner, so he doesn't have much fat anyway. He and his wife have really been an inspiration to Ron and me. It's so encouraging to see him doing so well too.

Take care, Cindy

[Birgitta-A]

Hi Cindy,
It should be very interesting with info from a patient that is treated with MS-275. As far as I understand it is common that patients respond at the 4th Vidaza cycle so this far his results are not different from other Vidaza patients. Did you get any info about his counts?

Hope Ron continues to feel better!
Kind regards
Birgitta-A

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He said his counts continued to drop through the 3rd cycle, and he started feeling better only after his 4th cycle. His counts did not start rising until after the 4th cycle. I can get more details to share... they keep all of their lab reports. I'll post more as I know....

But, so far, you're right, no big difference from normal Vidaza treatment. He just finished up his 5th cycle, and after the 6th, he'll receive the bone marrow biopsy to check progress. We stay in pretty close contact, so, I'll let everyone know how his progress is. Also, will find out exactly what his stage of MDS was. He had mentioned he was stage-4, but, I'll get the specifics.

Cindy

[Vera W]

I guess that four months is the standard time to have the BMB but after that first month of shots I felt so much better. All of these Vidaza tests are so new it will be interesting to see if by the addition of drugs like ms 275 we can suppress the bad guys into a dormant stage that would last forever? Wouldn't that be a breakthrough? One of my doctors patients who has MDS and PHN and was in really bad shape had such remarkable results from the Vidaza that they are writing her up! Keep up the good fight!!

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We just got home from Emory and Ron had the following lab results today:

HGB 9.6, Hemacrit 29.7%, RBC 3.06, WBC 1.9, Neutrophils 29%, PLT 277. Ron's feeling pretty good, but of course, tired. He's taking a nap now. (Like Vera said, Rest is very important).

Next doctors visit is Wed (5/13/09) for lab work again.

Continued Prayers that my husband will continue to improve with this Vidaza Treatment.

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Since last post, things have continued to look up. Ron's feeling better and seems to have a lot more energy. He's very upbeat too!

Here are the lab results from today...

HGB 10.4, Hemacrit 31.3%, RBC 3.11, WBC 2.6, Neutrophils 41%, PLT 239. We go back in 1 week for lab work only (5/20/09), then, Ron begins his 3rd Cycle of Vidaza on 5/27/09.

We praise God for his progress so far, and we continue to pray that he'll continue on this path... Thank all of you for your prayers and your support. You are all an incrediable group!!! Full of stength and Hope... you've helped me & Ron tremendously and I gain strength from knowing you... and being a part of this group... again, "Thank you All"....

God Bless you All,
Cindy

[Birgitta-A]

Hi Cindy,
Congratulations to you both :)! Ron's HGB and platelets are really very good and the white blood cells are increasing too already.
Kind regards
Birgitta-A

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Ron continues to feel well & has energy. He tried to add a few extra hours at work this week and felt drained later after he got home. We talked about it and I convienced him he may be pre-mature about increasing his hours. He agreed to continue only on half days and to concentrate on continuing to "Rest" so his body can continue to heal...

Here are the lab results from today...

HGB 12.9, Hemacrit 39.0%, RBC 3.73, WBC 3.0, Neutrophils 45%, PLT 209.

All numbers are up more, except PLT, but, they have fluctuated over past several weeks, but, remained within normal band. I'm especially impressed with Ron's HGB increasing from 10.4 last week to 12.9 !!!! WBCs are on the rise too...

We continue to thank everyone for Prayers and Praise God for his response to Vidaza! We go back in 1 week (5/27/09), then, Ron begins his 3rd Cycle of Vidaza on 5/27/09.

PS. Ron initially had fevers and night sweats when first dx (Feb09). The fevers stopped after his last transfusion, just over 3 wks ago, and now the night sweats have stopped as well :-)

Thank you for your continued Prayers...
Cindy

[Birgitta-A]

Hi Cindy,
You know Ron's counts could not be much better - his platelet count is very, very good :). Many patients treated with Vidaza have really very low platelets and have to get platelet transfusions or get lower doses of Vidaza. Good that Ron was brave enough and entered the trial because Vidaza in a lower dose during 10 days in a 28 days cycle seems to be perfect for him.
Kind regards
Birgitta-A

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Birgitta,

I agree! The low dose is doing wonders for Ron! The great thing is, hopefully, through this trial, as with all of them, they learn what works better for some people, providing for more options! You're right about him being brave. I was so nervous (as you well know) when we had to personally "Choose" what option to go with... seems so overwhelming.

I am so HAPPY!!!! Continued prayers... I'll update all next week. By the way, we love Ron's doctor! He's awesome! He came wallking down the hallway while we were awaiting lab results. We didn't have a doctors appt yesterday, only lab work. We always have to stay to see results to ensure no tranfusions are required. The doctor stopped and talked to Ron a few moments asking Ron what he was up to. Ron smiled and said, I'm waiting to see if I need a transfusion. The doctor smiled really big and said, I don't believe you'll need one... Ron smiled back and replied, Neither do I...

Ron looks Fantastic!:)

Hugs, Cindy

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Today (5/27/09) was Ron's first day of his 3rd Cycle of treatment on clinical trial e1905. As previously mentioned, he is in the group that receives the 10 consecutive days of low dose (105 mg) Vidaza injections, he does not receive the additional pill (MS-275).

Today was another wonderful day for us reviewing the lab results... My spirit remains lifted and my heart continues to sing.. Praise God! HGB 13.1, Hemacrit 40.2%, RBC 3.86, WBC 3.0, Neutrophils 42%, PLT 250

Looking at previous labs (Last week), all levels have continued to increase a little bit, except the WBCs are holding steady at 3.0 so far. The Neutrophils are slightly down from last weeks 45%. I'll be very happy when the whites get up above 5000 and the Neutraphils are within normal % range.

Ron has had a lot of energy this past week, and I had to remind him to slow down. Seems he's trying to catch up on lost time... I'm trying to hobble him a bit so he continues to get the rest he needs to continue to heal. I'll update everyone next week.... and report how Ron's doing on the Vidaza this Cycle #3.

God Bless You All!
Cindy

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Today (6/03/09) was Ron's 8th day of his 3rd Cycle of treatment on clinical trial e1905.

HGB 13.9, Hemacrit 41.7%, RBC 4.04, WBC 2.2, Neutrophils 14%, PLT 336

Looking at previous labs (Last week), all levels have continued to increase a little bit, except the WBCs have dropped from last week's 3.0 to 2.2 and Neutrophils are way down from last weeks 42% to 14%.

Not sure what's going on with the WBCs/Neutrophils... but, I'm just praying it's all part of the process.... The clinical coordinator (Another Doctor) sat down with Ron today and told him she had reviewed all of his blood work and his progress so far, and they're fully expecting full remission by the end of the 6 mons treatment cycle.

As previous mentioned, I'll be at ease more when the whites start "Behaving"... I am very pleased with all of the other numbers and we continue to Praise God for the improvements.... and the good news the Coordinator shared with us today!

God Bless you All,
Cindy

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Today (6/10/09) was Ron's 15th day of his 3rd Cycle of Vidaza (by injection) treatment on clinical trial e1905.
NOTE: The cycles in this trial consist of 28 Days per cycle. Day 1-10 Ron recieves 105mg Vidaza by injection. Then, he's off 18 days.... but, has weekly lab work to check blood counts, etc.

Today, his blood counts were: HGB 14.5, Hemacrit 42.6%, RBC 4.16, WBC 3.9, Neutrophils 42%, PLT 226

Looking at previous labs (Last week), all levels have continued to increase, and I'm especially pleased with the WBCs increasing from last week's 2.0 to 3.9 and Neutrophils came up from last weeks low of 14% to 42%.

We were told it's normal for WBCs to bounce back and forth while receiving Chemo... I'm happy for them to keep bouncing "up".... and forget the "down"...


God Bless you All,
Cindy

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Today (6/17/09) was Ron's 22nd day of his 3rd Cycle of Vidaza (by injection) treatment on clinical trial e1905.

AWESOME LAB RESULTS TODAY !!!!

HGB 15.2, Hemacrit 43.6%, RBC 4.33, WBC 5.0, Neutrophils 56%, PLT 179

All counts have continued to increase, except the PLT did decrease some, but, still within the normal range. We're very pleased with Ron's WBCs!!!

We saw Ron's Doctor in the hallway and he smiled really BIG when he saw Ron's lab printout. Our doctor will be out of town next Wed when Ron begins Cycle#4 (Vidaza Injections), but, he said he wanted to set up an appt to discuss Ron's progress and future treatments. Ron's Clinical Trial coordinator said she just reported last week that Ron was doing exceptionally well on the 10-Day low dose regime... Not sure what this cycle will bring ... but, I'm thinking that perhaps Ron's BMB may come sooner than the clinical trial scheduled - month BMB...

NOTE: As far as "how Ron felt all week"..... He felt good all week, except for just one evening (2 nts ago). Ron said he didn't feel very good... that he felt weird. He mentioned his teeth/jaw hurt some and so did his back. He has had history with back/shoulder muscular/skeletal aches/pains, but, only recently teeth aching. He's been using the BIOTENE toothpaste the first 2 cycles, but, has now changed to "Sensidine" for sensitive teeth to see if that helps resolve anything... will let you now of future teeth problems/aches. The night he felt bad he said he had a headache too, so he took some tylenol. The next day he felt fine. Maybe it's MDS related.... treatment related, or just normal.... just felt bad one evening... it's hard to tell sometimes... I just mention these things for others to compare... etc.

Today we feel exceptionally Blessed.... And we continue to Praise God !!!

Cindy

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Today (6/24/09) was Ron's 1st Day - 4th Cycle of Vidaza.

LAB RESULTS:

HGB 15.9, Hemacrit 45.7%, RBC 4.57, WBC 4.0, Neutrophils 51%, PLT 170

HGB, Hemacrits, and RBCs overall continue to rise. WBC bounced back down a bit, but, we're still happy that they are at 4.0 and the Neutrophils remain above 50%. Ron remains on Antibiotics for now, PLTs dropped a bit more, but, still within range band.

We see the doctor next wed to discuss Ron's condition/progress. Seem the PA and the clinical coordinator were exceptionally pleased with results. We're happy because Ron is feeling "good".... it's nice having my "Guy" back...
We praise God for his progress and we pray Ron continues to be touched by God's Healing powers....

Cindy

[Birgitta-A]

Congratulations once more to the good treatment results!
Kind regards
Birgitta-A

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Birgitta,

Thanks for the continued encouragement you've provided over the past several months. I appreciate all of the members of marrowforums for their continued support.

You know, i continue to post Ron's progress, to encourage others... when we were trying to decide on treatments and learn about the e1905 clinical trial, seems I couldn't find a lot about it that was written in a way I could understand. I saw the flowerlady's post, asking if anyone is on it.... so, I thought, a continue posting under the clinical trial would be a good thing.

I am happy to be reporting the encouraging news that Ron's responding well... in hopes that this study provides more information for others... seems this low dose is perfect for Ron.... :-)

Hugs, Cindy

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Today (7/01/09) was Ron's 8th Day of his 4th Cycle of Vidaza on this clinical trial. He's scheduled for at least 6 cycles, then, will have another BMB to check progress. Today I was hoping the doc would say he's ready for a BMB now and we could see progress, but, the doctor said the BMB will be after the completion of Cycle #6. He said, for now, a BMB is not necessary, that, the blood counts are showing definate response to treatment. Ron will stay on schedule for a 6th cycle BMB.

LAB RESULTS:

HGB 15.2, Hemacrit 43.9%, RBC 4.40, WBC 3.7, Neutrophils 42%, PLT 236

Overall everything down a little bit, except for Platelets, they've risen. I was concerned, but, the doctor said we should be very happy, as the numbers do bounce up and down for everyone.. with or without MDS... that there weren't significant drops on anything and these results still show overall progress from where we started. Of course, the HGB is normal range, so, that's not a big concern... I just want the WBCs to behave right now and continue to climb up into the "Normal Range"...

Today though, they took Ron off the daily antibiotic. They don't feel it's necessary at this point and don't want to over use it.

Will post Lab results again next week...
Take Care & Praise God in all things.
Cindy

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Today (7/08/09) was Ron's 15th day on his 4th cycle of treatment. His last Vidaza injection was last Friday (7/03/09) for this cycle, and he has 18 days off before he starts cycle # 5. Today was definately another Day to Praise God for Ron's Wonderful Lab Results!

HGB 15.8, Hemacrit 45.3%, RBC 4.56, WBC 4.4, Neutrophils 44%, PLT 203

Everything Looks Good, steady progress, Vidaza Treatment working Wonders! Ron has tremendous Energy! Taking nightly walks... not too much, but, enough to get in some exercise. Ron says he Feels Great! And, that is what really matters... is how you Feel....

I continue to Pray for everyone with this dreaded disease and for their caregivers... God Bless All of you! Cindy

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Today (7/15/09) was Ron's 22nd day of his 4th Cycle of Vidaza (by injection) treatment on clinical trial e1905. He begins Cycle 5 next wednesday. (NOTE: I've been posting each wednesday's Lab Results so other patients can follow Ron's progress on this particular clinical trial...

Wonderful Lab Results Today !!!

HGB 15.6, Hemacrit 45.2%, RBC 4.55, WBC 4.3, Neutrophils 53%, PLT 158

The Medical Staff continues to be pleased with Ron's progress. We continue to Praise God for his healing touch... Ron continues to feel wonderful... and I am thankful for that...

NOTE: On a side note, a gentleman we had met in this same clinical trial actually is receiving the MS-275 med along with the Vidaza. He just completed his 6th cycle of Vidaza & MS-275 and his BMB showed No Blasts. But, because the WBCs are not behaving like the Doctors want, they have decided to continue him on more cycles of Vidaza, at the same 10-Day cycle w/MS-275. This gentleman had very very low RBCs, WBCs, and PLTs when first starting this trial. Is WBCs have been as low as "zero". Hopefully they continue to increase with additional treatments. During the trial, the WBCs have gotten up to 2.2 I believe. He does feel really good though and he's walking 3 miles per day. Transfusion Free.

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Today (7/23/09) was Ron's 2nd day of his 5th Cycle of Vidaza (by injection) treatment on clinical trial e1905.

Lab Results:
HGB 15.8, Hemacrit 45.3%, RBC 4.62, WBC 3.3, Neutrophils 39%, PLT 177

Today, Ron's numbers continue to look pretty good and he feels good. The only complaint he had the last two nights is that his teeth started hurting again. This has been happening off and on during the chemo treatments. (Tylenol quickly Relieves the pain)

We continue to Praise God for each day....

Cindy

[Birgitta-A]

Hi Cindy,
Ron's counts are so good that I feel that I should ask my doctor if i could try a 10 days cure instead of a 5 days cure as they usually give i Sweden. My counts are still OK with watch and wait so we wait with Vidaza so far.

You know "your" study started 2006 and needed 63 paticipants. According to clin trials gov the study now is active but not recruiting participants - I think that means that they now are starting to analyse the results. Perhaps we will be informed about the results at the ASH conference in Dec 2009.
Kind regards
Birgitta-A

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Birgitta,
It seems they're actually studying two different things in this trial... if I'm reading it right. The main study is for the Low-dose Vidaza for 10-Days with the added drug MS-275. But, the second control group (Which Ron's in), does not receive MS-275, but, does receive the lower dose (105mg) Vidaza for 10 Days each cycle. I believe they'll be able to see two things in this study... the effectiveness of low dose for 10-Days and the added MS-275, if that does anything to enchance effectiveness.

I know we're very happy with the minimal side effects (occassional teeth pain, but, quickly relieved with tylenol), and the increased counts. The most important thing is, Ron is feeling great!

The doctor did mention, after remission, Ron, of course, would continue on Vidaza. Initially he said, the 10-Days cycle would continue, but, then, he said, he would check the protocol, after remission on this type dose and see if he'd be able to slightly reduce the days of the injections. 10-Days is a lot each month to go to the hospital... but, if that's what it takes to keep Ron feeling wonderful.. then, we'll just take it easy for the 10-Days and we'll celebrate the 18-Days Free from treatment.

Talk later,
Have a nice Day! Cindy

[Birgitta-A]

Hi Cindy,
Yes now I can see that there are two different studies of Vidaza with or without MS-275 called NCT00101179 and NCT00313586.

The first one (that is closed) is a dose-finding trial and the second one is a randomized Phase II study where 152 patients will participate. We hope to be able to read the results from the dose-finding study i Dec 2009.
Kind regards
Birgitta-A

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Birgitta,
Ron & I both look forward to reveiwing the study results... and like you have said, seems the clinical study's lower dose for Ron seems to be perfect! If you decide on the same dose, i hope the same results for you. But, of course, the wait and see seems to be working for you right now... and I hope it continues :-) With Ron, he because so very weak and was sweating each night w/fever, etc... he needed some relief. I believe it was after the end of his 1st cycle & his last transfusion, the nightly sweats & Fevers stopped... and he started feeling "Normal" again...

God Bless,
Cindy

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I've not posted for 2 wks, so, today includes both 7/29/09 and 8/05/09 Lab Results. Ron continues to receive Vidaza by injection on clinical trial e-1905 (without MS-275 pill) for 10 Consective Days each cycle. (A complete cycle is 28 Days).

7/29/09:
HGB 15.7, Hemacrit 46.3%, RBC 4.68, WBC 2.5, Neutrophils 30%, PLT 226

8/05/09 (Today):
HGB 16.2, Hemacrit 45.4%, RBC 4.67, WBC 4.4, Neutrophils 49%, PLT 164

We saw the WBCs drop some during the end of the Chemo injection week, and then, 1 week later, we've seen significant improvement in the WBCs. We're Very Pleased and the Staff was too.

We Continue to Praise God Daily.... and are thankful for the "Good Days"... which, we're blessed to have had a lot of them over the pasts several months...

God Bless you All...
Cindy

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Here are Ron's compiled Blood Results since Cycle. I thought it was easier to see the overall picture of response by aligning the the comparisons.... Ron is on Clinical Trial (Phase II) Vidaza by Injection (10-Days) w/o MS-275.

The first number, for example, 2-10, means Cycle 2, Day 10. Followed by Date of lab work....

2-10: 5/08/09 HGB 9.6, HCT 29.7%, RBC 3.06, WBC 1.9, NEU 29%, PLT 277

2-15: 5/13/09 HGB 10.4, HCT 31.3%, RBC 3.11, WBC 2.6, NEU 41%, PLT 239

2-22: 5/20/09 HGB 12.9, HCT 39.0%, RBC 3.73, WBC 3.0, NEU 45%, PLT 209

3- 1: 5/27/09 HGB 13.1, HCT 40.2%, RBC 3.86, WBC 3.0, NEU 42%, PLT 250

3- 8: 6/03/09 HGB 13.9, HCT 41.7%, RBC 4.04, WBC 2.2, NEU 14%, PLT 336

3-15: 6/10/09 HGB 14.5, HCT 42.6%, RBC 4.16, WBC 3.9, NEU 42%, PLT 226

3-22: 6/17/09 HGB 15.2, HCT 43.6%, RBC 4.33, WBC 5.0, NEU 56%, PLT 179

4- 1: 6/24/09 HGB 15.9, HCT 45.7%, RBC 4.57, WBC 4.0, NEU 51%, PLT 170

4- 8: 7/01/09 HGB 15.2, HCT 43.9%, RBC 4.40, WBC 3.7, NEU 42%, PLT 236

4-15: 7/08/09 HGB 15.8, HCT 45.3%, RBC 4.56, WBC 4.4, NEU 44%, PLT 203

4-22: 7/15/09 HGB 15.6, HCT 45.2%, RBC 4.55, WBC 4.3, NEU 53%, PLT 158

5- 2: 7/23/09 HGB 15.8, HCT 45.3%, RBC 4.62, WBC 3.3, NEU 39%, PLT 177

5-8: 7/29/09 HGB 15.7, HCT 46.3%, RBC 4.68, WBC 2.5, NEU 30%, PLT 226

5-15: 8/05/09 HGB 16.2, HCT 45.4%, RBC 4.67, WBC 4.4, NEU 49%, PLT 164

[Birgitta-A]

Hi Cindy,
The increase of the HGB is amazing and the WBC:s are now perfect ;)!
Kind regards
Birgitta-A

[launch]

Birgitta,
Thanks! After Ron was a bit bummed last week when his WBCs were 2.5 (equates to 2500), I decided to list it out like this to compare his progress... let's just say, I'm with you... his improved HGB and even WBCs are amazing. I may have to pull out his original blood counts, because, before treatment, he was down to .70 and 1.2 (equates to 700-1200) on his WBCs and his PLTs were 82 (equates to 82,000). His HGB was going down rapidly and he was obviously going to need transfusions every other week since first dx.

We're so fortunate for this Clinical Trial... Low dose Vidaza, although it's 10-Days in a row of injections... has little side effects for Ron. His teeth pain didn't occur at all last cycle, and the only thing Ron complains about is, approx 3 days after his chemo (Vidaza) treatment, he feels kind of wierd. He says he's not tired, but, that he feels a bit "Jittery" ... like his sugar is out of whack, but, he is not diabetic or anything....

Have a Wonderful Week! If you ever go on Vidaza... I hope you do as well as Ron's doing! This low dose treatment, as you've stated before, seems perfect for Ron!

Hugs, Cindy

[launch]

Just an update... I haven't posted any of Ron's weekly blood results since 8/06/09. Last lab posts were through Cycle 5, Day 15 (5-15). I've added all lab results since that post...

Just as a reminder, Ron is on Clinical Trial (Phase II) Vidaza by Injection (10-Days) w/o MS-275. The first number, means, for example, 5-22, means Cycle 5, Day 22. Followed by Date of lab work....


5-15: 8/05/09 HGB 16.2, HCT 45.4%, RBC 4.67, WBC 4.4, NEU 49%, PLT 164

5-22: 8/12/09 HGB 16.0, HCT 44.9%, RBC 4.62, WBC 4.2, NEU 54%, PLT 126

6- 1: 8/19/09 HGB 15.9, HCT 44.9%, RBC 4.66, WBC 3.5, NEU 37%, PLT 157

6-10: 8/26/09 HGB 16.1, HCT 45.4%, RBC 4.68, WBC 2.9, NEU 28%, PLT 224

6-15: 9/02/09 HGB 15.4, HCT 43.8%, RBC 4.53, WBC 4.3, NEU 48%, PLT 164

6-22: 9/09/09 HGB 15.7, HCT 45.2%, RBC 4.65, WBC 4.6, NEU 50%, PLT 130

All numbers continue to look good. PLT down just a bit, but, the doctor doesn't really seem worried about that. We're happy to see Ron's HGB and WBCs holding nicely. We Praise God Daily and we Enjoy/Celebrate each day that he's in Remission. Based on Blood work, the doctor did tell us Ron's in Remission, but, he's scheduled for BMB next wed (9/16/09). His last one was at the beginning of his clinical trial and he had 5-6 chromosomal aberations and blasts were <5%. All blood counts were down and Ron was requiring transfusions approx every other week since first dx (Feb'09).

We keep all MDS patients and Caregivers in our prayers...
Cindy

[Birgitta-A]

Hi Cindy,
Now Ron must be near 6 months of treatment and his counts are excellent! Hope the BMB will show remission too!
Kind regards
Birgitta-A

[helen c.]

my husband had his bmb the 13th we will get results wed. he responded so well last year and had remission thru dec.09hes on weekly transfusion his platletts are rarely above 50 he doesnt get platletts until they are around 10hes on dseferal for iron 3 times a week. hes on 3 different antibiotics. he is so tired and his hip and shoulders hurt all the time hes on pain meds. i am going to ask for a copy of the reprt wed. i would like to hear what others think so we can make a decsion on his next treatment plan helen

[launch]

Birgitta,
You're right, this is Ron's 6th Month. I'll post again with the BMB results.

Helen,
I pray that your husband finds treatment to put him back into remission. I look forward to seeing his BMB results.

Prayers to all !!!
Cindy

[launch]

Ron completed his full 28-Day of this 6th cycle of Vidaza on the clinical trial e1905 w/o MS-275 and received his BMB on the day he would have normally started his 7th cycle of treatment. We received notification yesterday that his BMB revealed good results, and he qualifies to remain on the clinical trial... But we meet with the Dr next Wed to discuss details of the BMB and the treatment. The Vidaza will begin again on Wed, Sep 30th. And we'll just continue on the same treatment protocol for now... unless Wed reveals something else....

Initially, Ron's BMB showed Blasts under 5%. I'm not exactly sure what the exact blasts were the first time. I have the BMB, but, it's difficult to interpret, but, I will ask on Wed. Right now, Ron's BMB shows 0.7% blasts, and the staff is very happy with that. We were hoping for no blasts, but, we'll wait for next results and continue to pray...

We were a bit disappointed that there were still some remaining blasts, but, I guess we need to be patient and at the same time, be thankful that Ron's feel wonderful and that we're able to get out and about some.

It's just depressing sometimes, as I'm sure all who read these posts know... I mean, you'll have something planned, like, we had tickets to the Tenn Vs Auburn Football game, and we're having to try to unload the tkts we bought. Everything would have been fine, as we had planned around the Chemo weeks, based on the schedule, prior to the BMB, and now, the treatment has shifted and we're having to miss the game and will probably have to cancel another trip we had planned the end of November... Argh...

I know, it's a "Pity Party"... but, every now and then, we're all entitled to one :-)

Sincerely,
Cindy

[Birgitta-A]

Hi Cindy,
Good that Ron has so positive results!

You know as far as I understand blast cells are young or immature cells and the bone marrow always contains blast cells. You have to ask specially about the 0.7% blast cells.
http://www.oncologychannel.com/leukemias/bonemarrow.shtml
Kind regards
Birgitta-A

[launch]

Birgitta,
Thanks again for your "up-lifting spirit"... I appreciate your references and your posts! Reading the article helps me to understand more about the blast cells and see that his results are, in fact, awesome! I also keep reminding Ron, and myself :-) that, it's better to be cancelling a trip due to a scheduling conflict vs a required transfusion, etc.... better to have MDS under control, even if it means we delay a trip or change up a week.... it's just nice that we can now plan... as compared to how it was back in Early Spring... So, we are Blessed, and we Thank God for Ron's response to Vidaza. He has a wonderful team of doctors...

Before Wednesday, I also have another question... I know, I know... don't quit a "Winning Team" ;-) But, I wondered, Ron could go on 5 Days vs 10 Days... it would be the same dosage for each day.... (105mg)... the only difference would be, he would only get 5 Days vs 10 Days. The change would require he come off the clinical trial. My concern is, are there any studies showing the 10 Days is much better than 5 Days? If not, then, I'm thinking, the less toxins (chemo/Vidaza) in the system, the better... BUT, only if the 5 Days is proven to do the same as 10 Days??? Any advice? Ron has decided, whatever the doctor tells him to do is what he'll do, and I'm with him, but, I do have concern about taking extra days of chemo if not a benefit...

on the Flip-Side though, as you stated in another post, MDS is many diseases with shared symptoms. So, who really knows if the 10 Days may have caused Ron to respond so nicely, where the 5 Days may not have? I thought the response percentage was approx 50% to Vidaza, but, I've learned it's actually less than 50%, so, we should be thankful... and think twice before changing things up.....

<Lots to Think About>
Cindy

[Birgitta-A]

Hi Cindy,
You know I have never seen a report about 10 days treatment - they are beginning to report about Entinostat (MS-275) studies but not anything that is easy to understand and nothing about the control groups.

As I have written before my doctor, who is a specialist in MDS treatment, has told me that no one really knows the best doses of Vidaza.

Here is a report about 5 days treatment (56 % improved) that in this study was better than 5 + 0 + 0 + 2 days and 5 + 0 + 0 + 5 days treatment. All patients probably got more Vidaza than Ron has got.
http://www.oncolink.org/resources/article.cfm?c=3&s=8&ss=23&Year=2009&Month=3&id=16098
Kind regards
Birgitta-A

[launch]

Birgitta,
Thank you! Ron begins Cycle #7 of Vidaza tomorrow... and so far, we're planning to continue on the 10-Day cycle on the clinical trial. I have some questions tomorrow for the doctor.

Will keep you advised... Ron will receive Labs tomorrow, and I'll post results.

Cindy

[launch]

Today was a good day... we asked a lot of questions about continuing on the clinical trial protocol (10-Days Vidaza) on a 28 Day Cycle. Ron is approved to remain on the trial, as his blood is considered in Full Remission and his Bone Marrow is considered in Partial Remission due to some blasts... but, when I asked about all of us having some blasts, the Doctor confirmed what Birgitta had shared in earlier posts.... that we all may have blast cells at some time...

I also asked if there were any "knowns" as to 10-Days being better than 5-Days, or 5-Days being just as good as 10-Days... The doctor did say, right now, it is "unknown".... and there were really no way to determine if 5-Days or 10-Days would be best.

Also, I did confirm Ron's dosage... I had noted previously it was 105mg. That is what he receives due to his body weight & Height, but, the actual prescribed dose 50mg/m2.

We've decided to continue with "The Winning Team" and stay on the clinical trial protocol with the 10-Days Vidaza. Ron's Labs looked great today!

7- 1: 9/30/09 HGB 15.5, HCT 44.6%, RBC 4.60, WBC 4.6, NEU 45%, PLT 204

Thank all of you for your continued support & prayers. And, may God Bless all of you !!!! Patients & Caretakers! Cindy

[Birgitta-A]

Hi Cindy,
It is really very interesting that Ron is getting less Vidaza each day than the recommended dose but during a longer period - 50 mg/m2 for 10 days compared to 75 mg/m2 during 5 or 7 days.

Perhaps many patients should do better with a lower dose during a longer period. You know patients with CML take Gleevec every day to keep the malignant cells down and control that their counts don't decrease too much.

Good luck with the treatment!
Kind regards
Birgitta-A

[launch]

Todays is Ron's Cycle 7, Day 8 of Vidaza. His Lab Results are incrediable! He's a bit tired during his chemo days, but, still is feeling good... He really feels good, a few days after his last day of chemo injections... his cardiologist put in back on Baby Aspirins (Coated) 81 mg. previous to MDS dx, he was taking 325mg of coated aspirin due to him taking Niaspan, which, causes him to "Flush"... While they've cut back the Niaspan from 200 mg per day to 1000mg per day, Ron stil has a flushing problem. They're trying him on the baby aspirin (81mg) to see if it helps. He's been on it now for 1 week. We'll keep a close eye on Platelets for effects.

7-8: 10/07/09 HGB 14.7, HCT 59.0%, RBC 4.30, WBC 5.6, NEU 54%, PLT 131

We continue to Praise God for Ron's success and progress!
Cindy

[launch]

Today I'm posting Ron's Lab results that were taken this past Wednesday (10/14/09), which was Cycle 7, Day 16. Again, we are pleased with his continued good blood counts on Vidaza...

7-16: 10/14/09 HGB 14.3, HCT 41.5%, RBC 4.20, WBC 5.2, NEU 52%, PLT 122

As mentioned in previous post, Ron began taking Baby Aspirins (Coated) 81 mg a week ago. He said something was making him feel weak and just kind of weird. He believed it was the aspirin. He has stopped taking it after only 5 days and he feels fine again.

PTL!
Cindy

[Vera W]

Hi Cindy, good job you guys!!! Doesn't asprin lower your counts? Looks like it did a bit. Take care

[launch]

Hi Vera,
Yes, aspirin can lower counts. Previous to dx, Ron was taking 325mg daily and was taken off of that. His counts were holding good, and they decided he could try the 81mg daily to help off-set the symptoms (Flushing) when taking his Niaspan at night, but, I see his PLT were lower this week too. So, it was probably a combination of the aspirin and the chemo injections knocking them down.

Thanks for your post. I Also want to congratulate you on your transplant success! You are such an inspiration to so many people!!! Thanks for sharing your journey! And, I will keep you in my prayers for your continued restoration of health!!!

Hugs, Cindy

[launch]

Hello Everyone. I've not posted since 10/17/09. Ron didn't feel as good on his 7th & 8th Cycle as he did during his previous cycles. He really felt run down, although his Blood Counts continued to look good.

Aside from Ron's MDS Condition, he developed an "Unrelated condition" that really put a damper on the past few weeks.... During Ron's 8th Cycle he had a problem with Burning senstation when he urinated and he had to go very frequently.

The medical staff has determined that his condition was "unrelated to Vidaza"..... but, of course, anytime your immunity system is lower than the average person, it much harder to fight any new development and/or condition....

Who knows, perhaps this condition, combined with his Vidaza injections is why he had a really "Run down feeling" these past several weeks...... That's what I have a tendency to believe...

Ron's family doctor put him on Flomax due to his history (2 yrs ago) having enlarged prostrate. He was also prescribed Pyridium for burning relief. This was on Friday (Day 3 of Cycle 8 Vidaza). It only got worse, and Ron then mentioned this to the on-scene doctor while getting his weekend Vidaza injections. That doctor believed it to be a Urinary Tract Infection (UTI). They collect Ron's urine for testing and he was told to start taking "Cipro" antibiotic. The Next day though, it was determined it was not a UTI & the Hemotologist told Ron he needed to see a Urologist ASAP. Luckily, Ron got a same day appt.

The Urologist prescribed Ron antibiotic Bactrim, and him to remain on Flomax, and to take Ibuprophin as needed to reduce inflammation. The urologist confirmed the prostrate was inflamed and told Ron he'd require antibiotics to treat bacterial prostrate prostitis.

On Thursday, (Day 8 of Cycle 8) Ron came down with a Fever, 101.9F during Vidaza injections and he felt really really bad. The Hemotologist recommended that Ron be admitted into the hospital and did not like that Ron was on Bactrim. He removed him from Bactrim, as it was NOT the antibiotic of choice for someone with MDS. AND, not to take Ibuprofin... (as it affects platelets).

The Hematologist recommended hospital admission and Ron agreed, as his fever continued to climb. That night, it shot all the way up to 104.4F. He was dilerious... and really doesn't remember anything about that night. He was in a lot of pain - lower back due to the prostrate inflammation, so they gave him pain killers and finally a one time administering of morphine. He was out like a light. They kept him on high-potency antibiotics by IV to try to help him break the fever....

The fever didn't let up until Saturday evening after Midnight... I had called my prayer warriers via email Saturday evening around 6pm when I came home to take care of my dog for a short... and take it to my friends house. Then, I was back at the hospital... and witnessed Ron's temperature fall below 100F just after midnight. It was awesome! They then changed his IV drugs and put him on Levaquin and continued to monitor temperature the next few days while inpatient. Finally, Ron was released on the following Tuesday... Let's just say, it was a Long Week!!! Ron was wiped out!

We had missed a planned trip while Ron was in the hospital, so, we re-scheduled for the following week. We were out of town for 4 days. We also had a planned trip this Saturday to travel to Cancun, MX, but, decided, it would be best not to leave country right now... just for safety sake... Ron is still on antibiotics and really can't afford to pick something else up right now... and if he did come down with a fever, he'd need to go right in the hospital to get it back under control until he "Kicks" this prostrate prostitis. The Urologist said it may take up to 30 days to fully fight this condition.

Ron still has a lot of burning and discomfort. He remains on Levaquin & Pyridium as needed. His hematologist checked his platelets and told him they were okay for Ron to take Ibuprophin for just 3-Days to try to get some relief with the inflammation.

Then, to come off of it. Meanwhile, when asking the Urologist again about the Flomax and purpose of taking it, the urologist said Ron should not be taking it now... with frequent urination... (Glad we Asked again)....

So, I'm sure you understand why I haven't posted the weekly Blood counts. we're headed out of town this Saturday for several days. I'll try to get the documents together & load up the counts for your review... as Ron continues on this clinical trial....

God Bless All of You!
Cindy

[Birgitta-A]

Hi Cindy,
Too bad with Ron's prostatitis! Infections are our most dangerous enemies. We never know when and how we will get attacked by different bacteria, virus or fungi. It is a problem when we need antibiotics and drugs for pain because they often give adverse effects like low platelets. Good that Ron is getting effective treatment :)!
Kind regards
Birgitta-A
So afraid of infections that I live like I have chronic neutropenia

[tytd]

Hello Cindy,
Thanks so much for all your posts which help others out there that might have to take Vidaza in the future. I hope that your husband is continuing to recuperate from his infection. I am posting this just because your husband's experience with other specialists is very typical and all of us with bone marrow diseases and low counts, especially WBCs and platelets need to be wary when we are given a new drug by someone other than our hematologists. Often these other specialists may not even know what the diagnoses of MDS or AA mean and what the possible risks of other drugs may do to patient's blood counts or risks of bleeding and infection. I would recommend that patients always check with their hematologist before taking any new drug prescribed by another specialists to make sure that it will not possibly interfere with their counts. Of course there is always a risk/benefit assessment to make before using any drug or treatment. Sometimes the communication between different doctors taking care of the same patient is not always ideal and patients need to make sure that "they are all on one page."

[launch]

Thank you for your post. We thought we were "Safe" because the Urologist worked in the same medical complex and our appt was set up by the Hematologist Nurse... but, like you said, they are not the MDS experts... and I agree, all needs to be run back through the Hematologist.

We've just returned from a 5-Day vacation in the Florida Keys. It was relaxing, but, it's always good to be back home. I'm just thankful that through all this, Ron & I were able to get-away for several days just to relax and re-group some... it's been a very trying year, but, Ron has responded well to Vidaza and we're thankful for his current progress....

Update: Ron still has discomfort with his Prostitis. We're not really happy with his current Urologist and fully intend on finding another one, starting tomorrow. He really wanted to see his current one, right before he left town to discuss his discomfort and lack of relief. The Doctor relayed through his Nurse, I won't see you because I don't know what to do for you....

Well.... "Ding, Ding, Ding... time for a new Urologist".... We've lost confidence in the previous one, so, we'll find another one... We don't expect a cure overnight, but, we need someone that's willing to work closely with Ron and try to help him get some relief. We've gone on-line to see other remedies, for example there is something called a "Sitz Bath".... and these are things Ron needed from his Doctor, to explain to help him get relief...

Okay, thanks for listening.....

PS. The Stone Claws Crabs were AWESOME!!! Ron doesn't eat Crab meat, but, he watched me eat my entire plate full! And the Key Lime Pie was Great!

Cindy

[launch]

Hello Everyone. It's been several months since I've posted about my husbands journey on clincial trial e1905. I have so much to share! I wanted to let all of you know that Ron is doing very well and I will post his blood counts and give you a full detailed update on his progress with the next few days!!!! We received very good news from his most recent Bone Marrow Biopsy..... more to come..... Cindy

[Neil Cuadra]

Cindy (and Ron),

We're looking forward to hearing your good news! :)

[launch]

Hello Everyone! As promised, I'm providing an update to Ron's ongoing progress while on e1905 Clinical Trial. (Because the first one was Too Long, I've broken it down into two separate Posts...)...

Remember, he is Not in the group that is receiving MS-275 pill.

I last posted 12/03/09 when Ron was having a tough time with a new condition, Prostatitis. We were not happy with his Urologist, and after 30 days of fiddling around with this doctor, we selected a new Urologist and could not be Happier!

Ron's new doctor was able to get Ron's condition under control within a week. Right now, Ron's about 80% better than he was. He continues to have ocassionaly burning after urination, but it's minimal.. as we continue on the treatment with this new Urologist. He and Ron's Hematologist/Oncologist are talking together, discussing the long term plan... The Urologist prescribed the following for Ron's Prostatitis: Levaquin 750mg daily, Q-UROL (Herbal Supplement w/Sawpalmetto), which is sort of like advadart, but, with less side effects. He takes this twice daily, and Celebrex for prostrate inflammation. The Ocologist concurs with this protocol, but, continues to monitor Urologists treatments/status.

Now, an update on Ron's Blood Progress: (I've put the clinical trial cycle number, following by the day of cycle). Ron is on 10-Days of Vidaza injection (low dose), followed by 18 Days off... totally, a 28-Day Cycle.


7Cy-22nd:10/21/09 HGB 14.3, HCT42%,RBC 4.16, WBC 4.2, NEU 37%, PLT136
8Cy-1st:10/28/09 HGB 14.8, HCT43.6%,RBC 4.30, WBC 3.2, NEU 37%, PLT212

8Cy-10th:11/04/09 HGB 14.8, HCT42.8%,RBC 4.24, WBC 3.5,NEU44%, PLT228
** Ron hospitalized on 11/05/09 due to high fever, attributed to Prostatitis.

8Cy-12th:11/06/09 HGB 12.9,HCT 36.8%, RBC 3.61, WBC 3.2, PLT158

8Cy-14th: 11/08/09 HGB 12.3, HCT 34.4%, RBC 3.38, WBC 3.2, PLT90

8Cy-15th: 11/09/09 HGB 12.9, HCT 36.2%, RBC 3.59, WBC 3.0, PLT90

8Cy-16th: 11/10/09 HGB 14.3,HCT40.6%,RBC 4.09, WBC 3.9, NEU57%,PLT107
** Ron released from hospital on 11/10/09.

8Cy-19th:11/13/09 HGB 13.7,HCT40.4%, RBC 3.96,WBC 5.0, NEU41%, PLT132
8Cy-22nd:11/18/09 HGB 13.8,HCT40.7%,RBC 3.93, WBC 3.6, NEU41%, PLT141
9th Cycle: 11/25/09 HGB 14.6,HCT42.9%,RBC4.12, WBC 3.1, NEU38%, PLT185
** Ron’s treatment (Cycle #9) delay for 1 week (personal reasons, will check blood before leaving town. Will resume treatment on 12/09/09.

9th Cycle:11/27/09 HGB 13.7,HCT40.5%,RBC 3.88, WBC 4.7, NEU62%, PLT107
9Cy- 1st: 12/09/09 HGB 13.6,HCT40.5%,RBC 3.89, WBC 6.5, NEU 58%,PLT173
9Cy-10th:12/16/09 HGB 12.8,HCT38.8%,RBC 3.71, WBC 5.4, NEU61%, PLT122

9Cy-15th: 12/23/09 HGB 13.3, HCT38.5%,RBC 3.77,WBC 5.0,NEU58%, PLT102
9Cy-22nd:12/30/09 HGB 13.6, HCT39.9%, RBC 3.88, WBC 3.4,NEU 53%

10Cy-1st:1/06/10 HGB 13.6, HCT39.9%, RBC 3.87, WBC 3.6,NEU52 %, PLT180

10Cy-10th: 1/13/10 (Lab Work Not available for post)

10Cy-15th:1/20/10 HGB 13.7, HCT40.6%, RBC3.87,WBC 4.3,NEU48%, PLT 145
10Cy-22nd:1/27/10 HGB 13.7,HCT40.5%, RBC 3.88, WBC 4.7,NEU62%, PLT107

BMB (2/3/2010): Bone Marrow Biopsy- Treatment Delayed 1 week

Labs 2/3/10: HGB 13.6, HCT 39.7%, RBC 3.83, WBC 3.6, NEU 47%, PLT168

11Cy-1st: 2/10/10 HGB 14.0,HCT 41.7%, RBC 4.02, WBC 3.3, PLT219


Please see next post for updated status... Cindy

[launch]

Ron's feeling a bit Run down about Day 5 of his cycle of Vidaza, and feels really run down until 3 days following his last injection. So, of his 28-Day cycle, Ron feels bad Day 5-13. During Cycle 10, we had visitors from Brazil, and the husband that was visiting us developed a cold while he was here, and the baby immediately developed one too.... needless to say, we couldn't stay away from them, they were visiting us... but, looking back, Ron should have wore his mask, or they should have worn one. First, they thought it was just the dry air from the trip, etc.... but, who knows..... They stayed 10 Days, and the day before they left, Ron's throat started getting scratchy, and after they left, he got really sick... Some fever, for 2 nts, between 100-101.9F. Ron developed a full blown sinus infection, and due to the fact he was already on Levaquin, it was determined to change his antibiotic to Augmentin.

You see, the chosen antibiotic had to meet the Urologists needs and also be okay by the Hematologist. Ron was prescribed 500mg Augmentin twice daily. A week later, it was not better, so when Ron saw his family doctor, the Augmentin strength was increased to fight the sinus infection... Ron was told it should have been a stronger dose to start with... So, it was raised to 875mg twice daily. He's doing great now, and he's over the sinus infection, so, I called the Family doctor today to inquire "When he could come off the high dose of Augmentin"... and was told, he should have come off it after 1 week.... REMEMBER... ALWAYS be pro-active on your treatment..... Ron's follow-up was not until the first week of March, had we not asked, then, he would have continued the higher dose of Augmentin for no reason.... This evening, I'll email Ron's Urologist, because, I suspect, he'll want Ron back on the Levaquin 750mg once per day.

NOTE: Normally, a Urologist would put a patient on Bactrim, but, this antibiotic is not the choice for patients being treated for MDS... So, levaquin was the antibiotic decided on... And, with chronic prostatitis, long term antibiotic is often the treatment protocol. We really Love the Urologist that Ron has now! He really shows interest and he "Cares about Patients".. plus, he knows you have to treat each and every person according to their condition... No one person is the same... and therefor, no treatment protocol is the same. He's also very responsive to "Email" contact, so, that makes it very nice for us....

And, the FINAL news... (Sorry this is so Very lengthy)... I should have posted more sooner.... Ron had a Bone Marrow Biopsy (BMB) Feb 3rd and the results are Awesome! Previously, Ron had 6 aberations of DNA abnormalities.... the results now show his only aberation is -5q deletion. He's been offered the opportunity to come off the clinical trial (e1905), if desired, and take Revlimid by pill form.

Decisions - Decisions? Well, as I've previously posted, Ron and I are very concerned about changing anything that works.... "Quitting the Winning Team"... the downside is, Ron's starting to feel really really run down during his 10-Day cycle of receiving Vidaza injections. About 6 wks ago, we decided, we wanted to travel to Moffitt Cancer Center in Tampa, FL to visit with Dr. List to discuss other protocols. We've discussed this desire with our Emory Doctor, and he knows Dr. Lists very well and encourages us to seek additional information. He will work together with Dr. List and collaborate on Ron's treatment... as we will decide if we change up, or stay with what Ron's currently on.

Our appointment is Mar 3rd, and all of Ron's records (including BMB slides) have already been forwarded to Moffitt to review prior to our appointment. Amazingly, Dr. List is the "Expert" on the -5q deletion and the drug Revlimid...

And, we have been praying all along for "Guidance" and "Signs"... we just take one day at a time... but, right now, we're feeling pretty good about Ron's progress and we Praise God every single day! We also look to the future, as the Sun continues to Shine.....

We continue to pray for all of you, patients and caregivers alike!
Next time, I'll try not to wait so long to post.... so, you don't have to read a Novel! Thanks for your support! I appreciate this forum more than any of you even know!

Hugs, Cindy

[Vera W]

Hi Cindy, sorry that you two have had such a rough time of it, I was worried about you. If the revlind doesn't work could he go back to Vidaza? Stay Strong, Vera

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We asked the Doctor that and he said, if Ron starting taking Revlimid, then, his other aberations returned, then, yes, he could start taking Vidaza again... But, will it work the same... second time around? Know one Knows.

We're going to see Dr. Allan List at the Moffitt Cancer Center in Tampa, FL before we make any decisions. We continue to be thankful that Ron is responding well, to Vidaza.... Thanks for checking in! Cindy

[launch]

Hello Everyone!

Ron & I just returned from Moffitt Cancer Center after a second opinion with Dr. Alan List. We were very impressed with Dr List and his staff and brought back some very valuable information. The first thing learned is, that, second opinions are paramount!!! While we're very happy with our Doctor at Winship Cancer Center, we were just at a point that we were very very confused and needed more information.... this trip to Tampa, FL gave us exactly what we needed.....

We met with Dr. List and he was very impressed with how well Ron (My husband) has responded to Vidaza (Low Dose) as part of this clinical trial. He said, if Ron changes protocol, his dose would increase, and he would probably not experience any more side effects, but, he recommends against ANY CHANGE to his current treatment... so as not to change the response....

I believe we asked Dr. List 6 different times, and in 6 different ways, if Ron could come off 10 Days of chemo per month and reduce to 7, 5, or 3 days... and he consistently said... "Don't change Anything"..... he said...
"Not to Rock the Boat"... if the body is responding so well to a protocol... why change what you're doing????

Also, we asked if Ron should change to Revlimid treatment vs Vidaza and was told no. REASON: While Ron use to have 6 aberations (Including -5q deletion), and since starting Vidaza, 5 of his Aberations have been eliminated, and he now only has the -5q deletion... normally treated with Revlimid... but, we were told that Revlimid will not "Fix" the -5q deletion, but, would help correct the associated anemia... so, with Ron not having anemia.. Dr. List has recommended against changing from Vidaza to Revlimid... but, the one thing they said to watch was... Ron's -5q deletion "Cells" have increased over the past year, while the other aberations have been eliminated.... we need to keep an eye on this. We pray the -5q deletion will eventually go away..... and Ron will be in total and complete remission next BMB.... (Please keep him in your Prayers)

So... what do we do now??? Ron was also told... just to live life... stay active, and enjoy everyday... that he is expected to be around for many years.... so, we are thankful for a great report and the affirmation of what we're doing.....

Latest Lab results: 3/03/10 HGB 13.9,HCT 39.9%, RBC 3.91, WBC 3.38, PLT98
So, thank all of you for your continued prayers! We praise God for Ron's progress and we thank God for his healing touch!

Hugs, Cindy

[launch]

I've not posted for sometime, so this note is long overdue. My husband, Ron, completed 13 Cycles of Vidaza by injection. He's on a 10-Day protocol, low dose Vidaza, followed by 18 Days off in between cycles. The past few cycles have seemed to really get Ron down some, although he refused to "Give in"... He's planted a small garden, he walks daily approx 2 miles, and he helps out alot around the house (i.e. laundry, etc).

Over the past 4-5 wks, we've noticed his WBCs haven't recovered like they once had been doing. Here's the counts from the past several weeks:

4/21/10: WBC 2.2
4/28/10: WBC 2.0
5/05/10: WBC 1.7
5/12/10: WBC 1.8

Seems once they started falling from 3.8, to 3.2, to 2.8, etc... they never recovered... we just kept watching them continue to fall. The neutraphils are at approx 36%, but, they did what they referred to as a Manual check on the WBCs, and they were below the required "500" count, so, for the first time, after completing 13 Cycles of Vidaza, Ron could not recieve his treatment as scheduled on 5/5/10. We were sent home and told to return in 1 wk, which, the WBCs were checked 5/12/10 with no improvement. The overall number was lower and Ron's Vidaza was once again delayed.

We go back on 5/19/10 to check again. If Ron's WBCs have recovered, then, he will continue on the clinical trial with a 20% dose reduction of Vidaza. If Ron's WBCs have not recovered, then, he will be disqualified from continuing on the clinical trial and will start a different protocol.

We're not sure what to think at this point. Of course we're very concerned, but, we have absolutely no control over the events in our lives right now... we just try to keep our spirits up & we're thankful that Ron's been transfusion free for more than a year now.... (Praise God!). We just try to enjoy every single day. We Thank God for Everday!

God Bless All of you!
Cindy

PS. I'll update all next week....

[Birgitta-A]

Hi Cindy,
Too bad that Ron's WBCs are decreasing! Can't he get Neupogen or a similar drug?

When his neutrophils are so low he should be very careful and avoid everything that eventually could cause infection. You know there are many sites about guidelines for neutropenic patients. We should for example not do anything like planting because we can inhale mold and get pneumonia.
kind regards
Birgitta-A
Neutropenic fever Sept 2007. Since then avoiding everything that could cause infections though my WBCs are normal due to 2 injections Neupogen/week.

[launch]

Hi Birgitta,

Thanks for the info, I didn't even consider the garden could be a bad thing :( but, will let Ron know. And as far as receiving Neupogen, I will ask that question on Wednesday next week. (Ref: clinical trial rules, etc).

Right now, Ron is on Augmentin antibiotic, still fighting against his Prostatitis... which has recently flared up more than it had been the past few months. All could be part of low WBCs and increased infection, thus, inflammation, etc.

Also, I recently heard, from one of the Staff at Moffitt, that some Doctors, while not scientifically proven, believe sometimes Neupogen can result in increased Blasts? Have you heard anything like that?


Cindy

[Chirley]

Hi Cindy,

There seems to be differing opinions on whether Neupogen increases blasts. My doctor doesn't like to use it unless he absolutely has to. My neuts run at about 0.1 to 0.2 now and he still doesn't want me to have it. I just have to accept his judgement.

[launch]

Chirley,

Thanks for the reply - we'll keep that in mind too, if our Doctor is against it. My huband's WBCs were 0.7 in the very beginning and the shot was never suggested at that point, but, he was put on preventative antibiotics. Ron has also remained on Acyclavir the entire treatment time, to prevent against Shingles.

Cindy

[Birgitta-A]

Hi Cindy and Chirley,
As far as I understand Neupogen and similar drugs can increase the risk for AML in patients with immunosuppresive therapy for example for AA but not for MDS patients with drugs like Vidaza:
http://www.anemia.org/professionals/reviews/content.php?contentid=310&sectionid=14&topic=

You know Chirley that your neutrophils are very well functioning :) - most MDS patients will get infections when they have so low neutrophils as you have. Remember that infections often are life threatening in MDS.

Ron is already having an infection - prostatitis - that is consuming WBCs. When they get low the prostatitis gets worse and the WBCs are decreasing. It is an evil circle.

Here is one of the many sites about neutropenia.
http://cancerinfo.cancer.iu.edu/cancerportal/public/symptoms/neutropenia.php#6
Kind regards
Birgitta-A
2 injections Neupogen/week since neutropenic fever Sept 2007 with good effect on my WBCs but I am still vary careful because WBCs can't help me if I get virus or fungi. We all have virus and fungi (and bacteria) living for example in the mouth and they can harm us when we get neutropenic.

[helen c.]

is anyone on this trial and if so what are your results

[launch]

Birgetta,
Thank you for the information, and explaination concerning Neupogen and increased blasts. We'll see what Wednesay's Lab work and appt brings.

Hugs, Cindy

[launch]

Today Ron's WBCs were increased to 2.3 but the overall calculation (Manual DIF - Differential) was less than the required 500 count to recieve chemo today (According to clinical trial rules). We asked the Doctor if Ron had been "off the clinical trial today" would he have received chemo (Vidaza)?

Our doctor answered that he would not recommend receiving Vidaza right now, even if not on the clinical trial. He told us not to become over anxious and not to get "in a hurry" about making any decisions right now, due to Ron's current condition.

Ron feels good, he has lots of energy, and isn't run down at all right now. Today his HGB was 13.7, matter of fact, all counts looked good, although I like the WBCs to be higher. They said Ron's WBCs show progress that they are coming back up with the delay of treatment.

What Next? Next Wed, we will return to the clinic and discuss situation. If WBCs (Manual-DIF counts) allow Vidaza, then, Ron will be able to continue on clinical trial (According to today's report of what the clinical trial allows). Initially, we thought Ron was automatically off the trial if Vidaza delayed another week.

The doctor assured us he would not recommend anything that he believes would be detrimental to Ron's health. Ron's due a BMB in the next 4-6 weeks, regardless if he's on or off clinical trial, so, we'll be able to see how the marrow is behaving.

We felt today was a very encouraging appt, because, the Doctor is not worried. He assured us that this reaction to Vidaza is common (the norm), and that, when this happens, the body needs a break.

I will update all next week.
God Bless all of You, Cindy

[Birgitta-A]

Hi Cindy,
Good that Ron's WBCs have increased and that he is feeling OK with a very good HGB :)! The neutrophils should be about 50% of the WBCs so they are lagging a little behind but will hopefully recover too.
Kind regards
Birgitta-A

[launch]

Birgitta,
Thank you for the encouragement. Sometimes I get my worries ahead of the actual treatment... meaning... I'm worried if we come off clinical trial and do the "Wait and See" as was discussed....

But, I'm quickly learning, it's better to try to just enjoy everyday and not to get worked about the "What If's", etc... They will drive you absolutely nuts!

Hugs, Cindy

[launch]

:)It was a good ride... on clinical trail e1905. Today it was recommended that Ron no longer continue on this clinical trial. So, this will be the last post on this clinical trial for Ron. I'll start a new entry, to report on Ron's monitoring, blood counts, how he's feeling, etc. So, Ron's on "Watch-n-Wait-Pray". Will keep you all updated. As we left the clinical, it was as if a weight had been lifted from our shoulders.... we keep praying and keep Praising God's Holy Name, thanking for Direction/Guidance/Healing.

Here is what was shared with Family & Friends via email this evening:

Ron's White Blood Cells (WBCs) had improved tremendously today and while Ron was qualified to continue on clinical trial, his Doctor strongly recommended against continuing chemo treatment. Ron is in remission, and the Doctor wants to monitor Ron without administering more chemo. The doctor is concerned that, while Ron's in remission, if he continues to recieve chemo, then, it may beat his WBCs down to a point eventually, that they don't recover. He said, Ron can continue in remission and not require any additional treatment for 6 mons or even 2yrs or more. Ron's blood counts will be monitored every 2 wks to start with and then, once per month. The Key right now is, Ron feels & looks Great!

We thank God for the wonderful Medical care and Medicines made available to Ron. We openly Praise God and give him all of the Glory for Ron's healing! We are so thankful to all of you for the prayers that have been lifted up to the heavens from all over the world! (United States, Brasil, Japan, Korea, Sweden, Germany, etc.) just to name a few.... We even received a hankerchef in the mail the other day from Janice (Ron's sister)... her church had annointed it with oil and prayed over it for Ron's healing... these prayers are the reason Ron & I are making plans again..... Just to Live Life Normal Again.....

But, will we ever really be "normal again"? No... I don't believe we'll ever be quite be the same.... somehow Life and Living has an entirely different meaning now. You see, these situations make you acutely aware of just how short life is here on earth and how quickly you can go from being healthy to being ill.... and without God, I don't how we would have gotten through this ordeal.... And, about life... I just remembered a saying I once heard.... "Today is a Gift. That's why we call it the Present".

And, just to share.... These scriptures listed below (NIV) have especially touched me: Psalm 18:2 "The LORD is my rock, my fortress and my deliverer; my God is my rock, in whom I take refuge. He is my shield and the horn of my salvation, my stronghold." Psalm 31:3 "Since you are my rock and my fortress, for the sake of your name lead and guide me"
Psalm 46:10 "Be still, and know that I am God; I will be exalted among the nations, I will be exalted in the earth."

Cindy

[Birgitta-A]

Hi Cindy,
Ron has really had good effect when he tried Vidaza low dose but when his dr suggests watch-and-wait due to low WBCs then everything must be less complicated. As you know I prefer watch-and-wait with high quality of life since I got my dx 4 years ago.

Hope Ron's WBCs will continue to increse when he isn't taking Vidaza!
Kind regards
Birgitta-A

[launch]

Birgitta,
Just keep Ron in your Prayers.... I too hope the same and keep the faith that he will do well. His Doctor actually wanted to go to the "watch and wait" because of the slow recovery of WBCs ( 4 wks ) Delay of next cycle of treatment. He said that, over time, his experience showed the recover time would be longer and longer, and he didn't want to push Ron's body to the point it did not recover. He didn't want to do more harm than good, just for the sake of keeping Ron on cycle...

Ron's body had taken the chemo harder the last two cycles. Seems he felt more effects of the chemo than before. My belief is, he felt so very bad in the beginning (tired, anemic, short of breath, slightly nausiated, and nightly fevers), so, as the Vidaza did it's magic, Ron's body was improving and the blood was behaving over time. But, once he had achieved the fairly "normal ranges" of blood counts, his body started getting run down by the same treatment that restored his blood counts. It's a double edged sword I suppose.

4 months ago, we were afraid of the watch and wait. Today we are not. We will take one day at a time... right now, Ron's quality of life is much better. He needed the Vidaza to bring him to this point. The Doctor is hopeful Ron's counts/remission status will remain for at leat 6 mons to 2 yrs. We keep our faith and we continue to pray...

I will keep all of you posted....
Thanks for always being there Birgitta!

Cindy

[Birgitta-A]

Hi Cindy,
Yes, as far as I understand all chemo are double edged swords. We can only hope that we get more positive effects than negative since all cells in the body are affected.

I looked at the new abstracts about MDS from the European Conference but the reseachers have not yet managed to find out what kind of cytogenic aberrations that will tell us who will have good response when they get Vidaza. It is still only Revlimid for -5q and ATG for a subgroup of RA patients.
Kind regards
Birgitta-A

[launch]

Birgitta,
The interesting thing we learned when going to Moffitt Cancer Center, was, Revlimid will only help "Anemia" for the -5q deletion patients, but, it wouldn't "Fix" the -5q deletion aberation in the marrow. That's why, when we were offered Revlimid, once Ron's aberations were reduced to the -5q deletion, and we went to Moffitt for a second opinion, we were told this bit of information. And, we were reminded that Ron's not currently showing signs of Anemia, so, the Revlimid would ineffective.

I always thought the Revlimid would work on getting rid of the aberation itself. Do you have any info on this?

Thanks, Cindy

[Birgitta-A]

Hi Cindy,
As far as I understand Revlimid (lenalidomide) can increase all kinds of blood cells. In this abstract they report that "treatment significantly improved the clonogenic potential of bone marrow erythroid, myeloid, megakaryocytic colony-forming cells" - that is early red blood cells, white blood cells and platelet produsing cells.
http://www.ncbi.nlm.nih.gov/pubmed/19773257
Kind regards
Birgitta-A

[launch]

Thanks again Birgitta,
We appreciate the information... Cindy ;-)