Onconova Trial

[Paula W.]

Just wondering if anyone has heard of or has been on a new trial called Onconova. It's a trial for MDS patients whose other chemo (i.e. Vidaza) has failed. It sounds promising, just wondering if anyone had any info on this.

I'm taking my Mom to Mount Sinai in NYC next week to meet up with the trial Doctor.

Thank you for any info.

Paula

[Birgitta-A]

Hi Paula,
Here are results from a small study with Estybon from Onconova. The patients had tried hypomethylating drugs like Vidaza or Dacogen before treatment with Estybon.
http://ash.confex.com/ash/2010/webpr...aper34755.html
Kind regards
Birgitta-A
71 yo, MDS Interm-1 dx May 2006, tx dependent from dx, Desferal and Exjade for iron overload, Neupogen for low WBCs, Thalidomide and Prednisone since June 2010 with good effect

[Greg H]

Hey Paula!

A number of medical centers are involved in trials of this drug, tradename "Estybon," technical name "ON01910.Na."

I don't think we've run across anyone on Marrowforums who has enrolled in the trial yet. But you'll find some additional information from the American Society of Hematology Conference in this thread.

Good Luck!

Greg

[Paula W.]

Thank you Greg, I will look into it. She should be going to the trial Doctor this week. I'll update progress as we go along. Happy New Year!

Paula

[Paula W.]

Thank you Birgitta,

I will look into the link. Thank you so much for the information.

Paula

[Paula W.]

My Mom will be starting Onconova next Monday the 17th, with Dr. Raza in NYC. It sounds promising and we are optimistic. I will keep you all posted as maybe this drug will help others as well.

Paula

[Birgitta-A]

Hi Paula,
Dr Raza is a very wellknown MDS doctor and I think your mother is in good hands. Hope she will respond!
Kind regards
Birgitta-A

[Paula W.]

Thank you Birgitta, We are very hopeful. We have to be right???

Thank you for your well wishes!

Paula

[Greg H]

Hey Paula!

I echo Birgitta's sentiments. Dr. Raza is one of the best. I hope the Estybon works for your Mom.

I, for one, am grateful to her for participating in a clinical trial that could help many of us MDSers one day. I hope you will pass along to her my thanks.

Do keep us posted on how things are going.

Good luck!

Greg

[Paula W.]

Will do Greg! We are hopeful and optimistic! She had the port put in today and is ready to go on Monday!

Thank you Greg and Birgitta for the encouraging words on Dr. Raza. She has been the most compassionate Dr. I have ever met. I hope all goes the way they are hoping.

Paula

[Paula W.]

My Mom started Onconova yesterday. It's administered through the port and the iv bag needs to be changed everyday for 3 days (72 hour drip). So far no side effects to mention.

We also got the bone marrow results yesterday. Dr. said that blasts are at 2% and she is considered low risk MDS at this point. I'm so confused because her local oncologist said that she has about 6 months to live, so I assumed she was high risk, now Dr. Raza said she is low risk......

Her blood levels are still very low, platelets are about 28,000, wbc 1.8 and hemoglobin is at 8.1.

We met a man at the hospital who is also on Onconova and he has leukemia. After 3 rounds of treatment his numbers have improved. Hope he continues on this path.

Will post as we go along.

Paula

[Greg H]

Paula,

It's hard to know why your local doc might have offered that poor prognosis. Did he (or has Dr. Raza) indicated what your Mom's IPSS score is? It's not that hard to calculate (and there's even a tool on Marrowforums that can help).

Looking at the numbers you just provided, she's below normal in two of three blood counts (and the WBC is borderline). So that would score 0.5 on the IPSS scale.

Her blasts are at under 5%, so she doesn't get any IPSS points for blasts.

0.0 for blasts + 0.5 for blood counts gives us 0.5.

Right now, we are at a score that give us INT-1. A lot of times, docs group the IPSS Low Risk and INT-1 together and refer to those patients as "Lower Risk."

All we need to know to complete the IPSS score is which cytogenetic abnormalities your Mom has. You can check that portion of the BMB report or ask the docs.

Were your Mom's counts or blasts worse when your local Doc gave you the six month prognosis? If you don't mind my asking, how old is she?

Hope that helps. It's nice to hear about the other patient's success with the drug. If you can come up with the cytogenetics we can figure out the rest of the IPSS score.

Good luck!

Greg

[Paula W.]

Hi Greg,

My mom is 77 years old. When she started Vidaza her blast was at a 9%, then went down to normal than increased by 5%, but I don't know what the actual number was. This is when she was told that Vidaza no longer was working and that she needed a trial to survive.

I have the full bone marrow report. (I can email it to you if you would like to see it). This is what I found on cytogenetic.

CYTOGENETIC:
46,XX[20]

This was also in the report. It's all gibberish to me, but maybe it makes sense to you.

DIFFERENTIAL CELL COUNT: 500 cells counted ------------------------------------------- ----------------------------------------------------------------- ----------------- CELL TYPE % NORMAL* CELL TYPE % NORMAL* ----------------------------------------------------------------- ------------------------------------------------------------ MYELOBLAST 2 0 - 1 PRONORMOBLAST 1 0 - 3 PROMYELOCYTE 4 1 -3 BASO NORMOBLAST 1 0 - 3 MYELOCYTE 6 2 - 10 POLYCHROM 6 3 - 20 METAMYELOCYTE 3 5 -15 ORTHOCHROM 3 0 - 8 BAND 6 10 -40 MONOCYTE 2 0 - 3 NEUTROPHIL 29 10 - 30 LYMPHOCYTE 35 5 - 15 EOSINOPHIL 1 0 - 3 PLASMA CELLS 0 0 - 3 BASOPHIL 1 0 - 1 * Adult range

Let me know if this info helps. Thank you for your help and information.

Paula

[Neil Cuadra]

Paula,

The format of your post came out wrong. Is this how the columns line up on your differential report?

DIFFERENTIAL CELL COUNT: 500 cells counted

CELL TYPE       % NORMAL* CELL TYPE % NORMAL*

MYELOBLAST        2         0         1
PRONORMOBLAST     1         0         3
PROMYELOCYTE      4         1         3
BASO NORMOBLAST   1         0         3
MYELOCYTE         6         2        10
POLYCHROM         6         3        20
METAMYELOCYTE     3         5        15
ORTHOCHROM        3         0         8
BAND              6        10        40
MONOCYTE          2         0         3
NEUTROPHIL       29        10        30
LYMPHOCYTE       35         5        15
EOSINOPHIL        1         0         3
PLASMA CELLS      0         0         3
BASOPHIL          1         0         1

* Adult range

[Paula W.]

Hi Neil,

Thank you, it makes more sense now. (I still don't know what all the numbers represent LOL). How I copied and pasted is how I received the email report. I have a MAC, so maybe the format isn't working right for my program.

Thanks again for clarifying.

Paula

[Greg H]

Hey Paula!

I'm not too smart about the various cell counts in a BMB, but your Mom's appear to all be in the normal range, with a couple of exceptions. The neutrophils are at 29, which is just 1 away from the high end of normal. The lymphocytes are way high at 35, when the top of normal is 15. So maybe your local doc was worried about transformation to some type of leukemia?

Anyway, the cytogenetics of 46,XX [20} means your Mom is female and has normal chromosomes.

So she doesn't get any IPSS points for cytogenetics. But the 9% blasts would have added 0.5 points, giving her a score of 1, which is still INT-1, lower risk.

I don't put much stock in the IPSS survival rates, since they are all based on data from before there was anything other than supportive care. The official IPSS prognosis for INT-1 is 3.5 years, but, like I say, that's based on data from before Vidaza and Onconova. Plus, every patient is an individual.

Hope that's useful. Glad your Mom's blasts have dropped so far from the 9%.

Take Care.

Greg

[Paula W.]

Thank you Greg for all the information. This disease seems to be such a roller coaster ride. Things change rapidly in both directions, good and bad. It's hard to keep up. Once you think you understand what is going on, it all changes.

My mom completes her first round of Onconova treatment today. Her second round will begin on the 31st. She goes for blood work in between the treatments. I will keep you all informed as we go along. I think it's important for all of us on this site to know about these trials, as they may be an answer to someone prayers!!

God Bless.

Paula

[Paula W.]

It's been 2 1/2 days since my Mom's first round of Onconova ended. She is physically exhausted. It can be from the drug or it can be a sign that her blood dropped. She is exhausted just moving about her home and she didn't go to church today, so I know she isn't feeling all that good. She goes for blood work tomorrow, so we should know if it's the drug or her blood then. If this is a reaction from the drug, so far it's the only one she has experienced thus far.

Paula

[Greg H]

Hey Paula,

Sorry to hear about your Mom's fatigue. In my experience -- and there's research that shows most other folks with MDS have the same experience -- fatigue is the main symptom of this disease. With me it comes and goes, and it's not always related to my blood counts, and, as I understand the research, that's pretty typical.

I'll often have a "bad" day and then, the next, feel great. It can kind of make you nuts.

I hope your Mom's current fatigue is very temporary -- and that you get good blood counts tomorrow!

Take care!

Greg

[Paula W.]

Hi All,

My Mom feel a lot better today, almost back to her old "beautiful" self. I did get her blood work, platelets dropped to 21,000 and Hemoglobin dropped to 8.0. The Doctor said that nothing was to be done, as far as transfusions at this time. Doesn't believe the drug had any part of the drop.

[Paula W.]

Well after days of her exhaustion increasing I brought her back for blood work. Hemoglobin dropped to 6. Blood dropped from 8 to 6 from Monday to Friday. She was sent for a transfusion which helped a lot. Not 100%, but much better. She goes for second round of Onconova on Monday.

[Greg H]

Paula,

Wow! No wonder she was feeling tired. I had one week like that back in December. I burned through two units of red cells in a single week. I was at 6.4 on Tuesday, got two units that day, and then was at 6.2 eight days later.

They decided to give me three units at that point, and it really helped get me back on track. I'm sure they will be watching your Mom weekly until things start to improve.

Good luck to you both!

Greg

[Paula W.]

Wow Greg,

Didn't know that the red cells can drop so quickly. I knew that the platelets only last a couple of days, but I thought the rbc lasted longer. This is the first time in approx 5 years she needed blood. Hope this going to become the norm. She goes for blood work tomorrow. I'll keep you posted.

Thanks for the input, I appreciate it so much.

Stay well!

Paula

[Paula W.]

Hi All,

My Mom finished her 2nd round of Onconova and again needed a blood transfusion. HB dropped to 7.7. 2nd transfusion in 13 days. Platelets rose a little 27,000 to 35,000 (we will take it). She also had blood along with her bowel movement the other day, which scared her a lot. I know the right thing is to take her to a GI dr., but I just don't want to put her through anything else.

She feels good, not great, more scared than anything. Her trial dr. is asking us to be patient and calm. I know this is good advice but hard to do.

She starts third round on Monday. I will keep you posted.

Good health to all.

Paula

[triumphe64]

You don't want to lose the blood at one end that you get transfused on the other. Talk to her trial doctor.