Clinical Trial or continue Vidaza???

[Al's Wife]

HELP!!!!
We had a very unsettling visit with our second opinion doctor today. He wants my husband to come off the Vidaza (my husband has had 5 cycles (months) of Vidaza with no improvement and he wants him to go into a clinical trial. The doctor said most people respond to Vidaza by the second cycle.
I've read and others have said that it took more than five months for the Vidaza to work for them.
My husband has never had to have a transfusion. His platelets have bounced between a low of 38,000 up to 60,000 since his diagnosis of MDS in May 2010. His WBC's and RBC's are normal. He does have three chromosome abnormalities.
Our thoughts are to continue the Vidaza for at least three more cycles with our regular oncologist. And if there is still no improvement then, we can consider other options.
The second opinion doctor said that there was only one slot left in this clinical trial study, so to let him know by Monday if my husband wanted to participate.
YIKES!
So what would you do if it were you? This is all so unsettling and scary. I really would appreciate any thoughts from any of you that have been down this road or are traveling along with us.
Thanks,
Linda

[Chirley]

Hi,

I was told that a lot of people don't respond to Vidaza for 6 to 9 cycles. I'm about to start my 5th cycle and no response yet.

The decisions you have to make about treatment options are difficult and all you can do is listen to each option and make your choice based on what feels right to you. I find the decision making one of the hardest parts of this disease.

Good luck.

Chirley

[mausmish]

What is the clinical trial? Is it potentially available somewhere else where enrollment doesn't close so soon? That way, you could try the Vidaza a little longer and then do the trial if it didn't work. http://www.clinicaltrials.gov/

[Al's Wife]

The clinical trial is Array-614. I think we're going to go ahead with our 6th round of Vidaza next week at our regular oncologist and also talk with him about what the second opinion doctor at Emory said about the clinical trial. And keep praying and hope we make the right decision.
Thank you for your input.

[Greg H]

Hey Linda!

I think you made the right call. The ARRY-614 trial is a phase 1 trial, according to clinicaltrials.gov which means its primary aim is just to see the maximum tolerated dose. The info is pretty sketchy on that website about whether there would be on-going treatment with the drug if Al showed improvement. But maybe your doc filled you in on that aspect of the trial.

It does sound like an interesting drug, but, if you're thinking about trying a clinical trial to actually get some treatment, as opposed to just doing a good deed, I think you want to be looking for a phase 2 or 3 trial. (I could be wrong, so someone correct me if I am.)

Everything I've read about Vidaza says don't quit 'til you've had six treatments.

Which of Al's chromosomes are messed up?

Hang in there!

Greg

[tytd]

Hello Linda,
I would agree with Greg about a Phase 1 trial and giving Vidaza a little more time. I forgot to look but what is Al's IPSS score? Is he high or low risk? Good luck. Tytd

[Al's Wife]

Thank all of you for your supportive comments. This is such a difficult disease with no clear-cut answers. Depending on which doctor you ask, my husband is RCMD Int-1 according to regular oncologist, and low risk MDS by the doctor at Emory. The regular oncologist gave my husband a prognosis of 1 to 6 years and the doctor at Emory said 10 to 15, hopefully, and then it will go into AML if he doesn't respond to any treatment or a cure is not found.

He has had two bone marrow biopsies (two different labs) which we learned on Friday showed different cytogenetics. I think that one lab mistakenly put a 3 instead of an 8 on the report, but this is only a guess on my part.
First biopsy on 5/12/2010 showed: 46,XY,t(8;21)(q23:q22.1)[17]

Second biopsy on 9/13/2010 showed: 46,XY,t(3;21)(q26;q22)[18]/49 idem,+8,+8,+9[2]

I have no idea what any of this means, although I have researched online to try and understand it. The doctor has said that my husband has a rare chromosome abnormality and there is only one other case with his specific chromosome abnormalities.

My husband so far has only low platelets (they have been as low as 38,000 and a high around 53,000). His HCT is 35.9, HGB 12.0, RBC 3.59, WBC 6.7. He has never had to have a transfusion. His only symptom is fatigue.

If anyone can interpret any of this for me, I would be very grateful. It is scary as the latest lab (as I stated in an earlier post) says:
"Although there is no significant increase in blasts, significant peripheral thrombocytopenia and cytogenetic findings suggest an unfavorable prognosis."

I'll post tomorrow after I talk to our regular oncologist. We are scheduled to see him in the morning and begin round 6 of Vidaza, which we are going to go ahead with. We have a call in to Emory doctor to tell him we have decided we do not want to do the clinical trial.

Thanks again for everyone's help. I couldn't get through this without all of you.

Linda

[launch]

Dear Linda,
Good luck tomorrrow and I pray the "Dose Six" is the lucky number! ;-) Sounds like you and Al made a good decision. And, Al is lucky that his only problem right now is the PLT counts. My husband, Ron, began the MDS journey with all problems.... Low Reds, Whites and PLT! so, all were affected. Ron was considerd low-risk as he was what is called Ringed-Sider Blasts MDS... but, the Moffitt doctor didn't think Ron was low risk in the beginning, before the Vidaza caused favorable response.... Ron always had a low risk to transition, and that is what REALLY surprised us when he did transition from MDS to AML.

Of course, always remember, as I was told. MDS patients share the same symptoms, but, due to DNA differences, everyone really has "Different Diseases".....

Good luck & stay in touch!
Hugs, Cindy

[Al's Wife]

Cindy,

Thinking of you today also as Ron begins treatment this week. Hope all goes well.
We were all set this morning to discuss things with our regular oncologist but when we got there we learned that his nurse's husband had passed away suddenly last Thursday and the funeral is today, so everything was crazy in the office. They were moving people's appointments, etc. so everyone could be off this afternoon to go to the funeral. So sad. He was only 53 years old.
So even though Al had labs and the first dose of round 6 of Vidaza, we were only able to see the PA and discuss things with her. However, we had already made up our mind prior to getting there that we were going to go ahead with the chemo today. They have scheduled us to definitely see the doctor on Wednesday though, so we can discuss things with him.
I appreciate everyone's input on the clinical trial. Since we are new to this (I'm sure like others, I had never heard of myelodysplasia or MDS before Al was diagnosed in May 2010), we do not have an understanding yet of how clinical trials work, etc. So we will definitely check things out before jumping into something we don't know anything about.
I did find an article online last night that said not to give up on Dacogen or Vidaza too soon because there are a number of patients who take a longer response time. So I'm hoping that is the case with my husband. Maybe Round 6 will be the charm.
Good counts to all,
Linda

[launch]

Hi Linda,
Sorry about the loss of the Nurse's husband, so young! Glad you found more supportive documents, confirming to give Vidaza another month. This disease is difficult to make decisions with, as, everyone is so different in their response. So far, So Good with Ron today. I'll post an update on the string of input I had started on him within this site.... Glad for your thoughts and prayers!

There are so many wonderful caring people on this site...!!!!! Love you All!

Cindy

[Birgitta-A]

Hi Linda,
Good that Al has so high counts - many doctors should wait with treatment but perhaps it is OK to treat early because it is difficult to find the best treatment for the individual patient.

As several members have written it is better to participate in a Phase II or III trial - many drugs are withdrawn after Phase I because they are too toxic for example for the heart or the liver.

The best treatment results I have seen so far are combinations of Vidaza and one of the so called histone deacetylase inhibitors (HDAC inhibitors). If you look at clin trials gov you can se these trials for MDS: http://clinicaltrials.gov/ct2/result...syndromes+hdac

There are 2 HDAC inhibitor drugs that are approved for other diseases - Zolinza and Epival - so these drugs can be prescribed off record without a trial.

You can use clin trials gov to see what trials there are for MDS where you live.

You know RCMD Int-1 is low risk MDS so both doctors tell you that Al has low risk MDS.

The reports about chromosome aberrations are too complicated for me too.
Kind regards
Birgitta-A
71 yo, dx MDS Interm-1 May 2006, transfusion dependent, Desferal and Exjade for iron oveload, Neupogen injections 3 times/week for low white blood cells, Thalidomide and Prednisone for bone marrow fibrosis since June 2010 with positive result, asymptomatic

[Greg H]

Hey Linda!

I am going to work on deciphering those cytogenetics for you. It's nuts that they have to write in such a complicated code.

I've had reports from two different pathology labs ow, and I notice that they do things slightly differently. But both my reports, in an area just below this gobbledygook, have a narrative description that looks like this:

43~46,XY,dup(1)(q21q32)[11]/46,XY[10]
The male chromosome complement is seen in which 11 of the 21 GTW banded cells analyzed had a duplication of the long arm of chromosome 1. Ten normal cells were observed. The findings are most consistent with myelodysplasia. In this study 21 cells were counted and analyzed and 3 cells were karyotyped at a band resolution of 400.

or like this:

46,XY,dup(1)(q21q32)[8]/46,XY[12].nuc ish (EGR1,D5S23,D5S721)x2,(CEP7,D7S486,D7S522)x2, (D8Zlx3)
Cytogenetic Analysis: Abnormal: Cytogenetic analysis revealed the presence of 2 clonal cell lines. The first cell line was chromosomally normal (60% of cells). The second cell line was cytogenetically abnormal with a duplication within the long arm of chromosome 1 that can be associated with myelodysplastic/myeloproliferative leukemia.

You might want to check your reports for something like that because it's easier to understand.

Take Care!

Greg

[Greg H]

Hey Linda!

I cracked the chromosome code. Here's what I found out:

First biopsy on 5/12/2010 showed: 46,XY,t(8;21)(q23:q22.1)[17]

That means:
46 chromosomes total (normal for human)
XY - He's a male.
t(8;21)(q23:q22.1)[17] - In 17 of the cells they analyzed, his chromosome 8 and chromosome 21 swapped some genetic material on their long arms.
Usually they look at 20 or 21 cells, so the other 3 or four cells were probably normal.


Second biopsy on 9/13/2010 showed two different abnormal cell lines:

The first cell line showed:
46,XY - He's still male, with 46 chromosomes.
t(3;21)(q26;q22)[18] - in 18 of the cells, chromosome 3 & 21 swapped some genetic material on their long arms.

The second cell line showed:
49 - showed 49 chromosomes total, instead of the usual 46.
idem - had the same swapping of the long arms of chromosomes 3 & 21.
+8,+8 - I think this means that there were four copies of chromosome 8, instead of the usual 2. It's called tetrasomy 8, if I have it right.
+9 - and it has an extra copy of chromosome 9, which is called Trisomy 9.

So that's what the codes all say. I wish I could tell you what they actually mean in terms of prognosis, therapy, and so on. But that's way above my pay grade.

Trisomy 9 shows up in a bunch of marrow failure diseases but is pretty rare. Trisomy 8 is a common one in MDS.

I'm sort of tempted to wonder the same thing as you are, looking at the first BMB and the second one: One of them has the wrong number after the "t("

On the other hand, this is a weird disease, and my transplant doc has said a number of times that particular abnormalities will sometimes come and go from one BMB to the next.

Doing some searching on the web, the t(8;21)(q23:q22.1) from the first BMB is reported in only one case, a man with RAEB. The t(3;21)(q26;q22) from the second one shows up in MDS and in AML and is linked to low platelet counts That association with AML is probably why you got that unwelcome "unfavorable prognosis" on the second BMB.

I hope that's useful.

On another note, I received the new newsletter from AA&MDS and saw in the cover article from Dr. Gail Roboz confirmation that you need to stick with Vidaza for at least six cycles before calling it quits.

If that doesn't work, I wonder if it might be good to look at one of the HDAC+Vidaza trials that Birgitta mentioned -- or maybe some other trial that's more oriented toward low-risk patients or specifically folks with thrombocytopenia?

Take care!

Greg

[Neil Cuadra]

My wife had different cytogenetic results in successive bone marrow biopsies. The particular abnormalities they identified weren't prognostic individually, but the doctor explained that the fact that her chromosomes were changing was a bad sign.

[Susan L]

Thank you for your response - I also have a hard time understanding my cytogenetic report. Your answer short and to the point helped me.

[Al's Wife]

Thank all of you so much, especially you, Greg, for cracking the code for me. Just trying to comprehend all of this is way beyond my brain power, if I have a brain left. But your interpretation along with everyone else's input has helped put it all in perspective. Maybe not in the way I would have liked, but, nevertheless, it is what it is.
We will just keep hoping for a cure as we continue our journey.
Thanks again to all of you.

Linda

[Susan L]

Hi - That was great interpretation. One smart cookie.

[sae36]

Originally Posted by Al's Wife

HELP!!!!
We had a very unsettling visit with our second opinion doctor today. He wants my husband to come off the Vidaza (my husband has had 5 cycles (months) of Vidaza with no improvement and he wants him to go into a clinical trial. The doctor said most people respond to Vidaza by the second cycle.
I've read and others have said that it took more than five months for the Vidaza to work for them.
My husband has never had to have a transfusion. His platelets have bounced between a low of 38,000 up to 60,000 since his diagnosis of MDS in May 2010. His WBC's and RBC's are normal. He does have three chromosome abnormalities.
Our thoughts are to continue the Vidaza for at least three more cycles with our regular oncologist. And if there is still no improvement then, we can consider other options.
The second opinion doctor said that there was only one slot left in this clinical trial study, so to let him know by Monday if my husband wanted to participate.
YIKES!
So what would you do if it were you? This is all so unsettling and scary. I really would appreciate any thoughts from any of you that have been down this road or are traveling along with us.
Thanks,
Linda

Hi Linda, I realize your post was dated from 2010, but I want to share this information with you, as your situation seems very similar to my father.

We took him to Stanford after finding this on Google -

http://mdsclinicaltrial.com/oncology...ite-locations/

The center enrolled my Dad in their MDS clinical trial. He has been through two cycles now, doing well and not as sick as when he started Vidaza a couple of years ago.