OncoVex trial

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9/11/2010 12:03am
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Replies: 8

Howdy,

My 3-month post-IL-2 PET wasn't what I hoped for - three new itty baby nodules in my butt.  One option my doctor is suggesting is the OncoVex trial.  It's the new phase III trial.  2/3 get OncoVex; 1/3 get subcutaneous GM-CSF in the control arm.  I thought of two questions that I didn't ask tonight, and am hoping somebody out there can give me some interim answers while I wait0for Monday to roll around.  First, does anybody know if the OncoVex trial has a crossover design?  (If I got GM-CSF and progressed, would I get OncoVex?)  Second, while I'm aware of the phase III trial results for adjuvant GM-CSF, I'm not immediately aware of any efficacy data for its use in active stage IV disease.  I have visited the trial page (http://www.oncovexgmcsf.com/index.html) and the NCI page (http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=617439&version=HealthProfessional&protocolsearchid=8173351) and cannot find the answers.  Anybody out there know more?

Thanks!

KatyWI

Just keep going!

lhaley - (9/11/2010 - 9:28pm)

Katy,

I'm sorry about the PET results. My local oncologist offered me the same trial this past week. I had talked to my mel specialist about a year ago and he didn't like this trial because of the possibility of getting the GMCSF while stage IV with active disease.  I know that the local onc was calling the mel specialist about this, will be interesting on what is said. Please post whatever info you find out.

Linda

Sharyn - (9/13/2010 - 9:03am)

Hi Katy,

I did the OncoVex trial last year, and got randomized into the GM-CSF arm. I started July 1/09, and when I had a brain MRI on Oct 16, it was discovered I had brain mets, plus, I had growth in mets to my lung and breast. I was disqualified because of the brain mets, but I don't thing there is a crossover design. If there was, I guess it would distort the data, because in the event of an eventual response on OncoVex, it could be argued that the patient was a late responder, and the response was possibly due to GM-CSF. I also know of a guy in California who started that trial as well, but was in the OncoVex arm, and he had disease progression too, and left the trial after 2 months. But everyone is different, and there are many different responses. All I advise is this: Once you make a decision on treatment, go for it, and don't look back. Good luck with it, and let us know what you decide, and how it goes.

Hugs

Sharyn

Stage IV

WLE, SNB, ILP, LND, PV-10, Uterine mets (Hysterectomy), GM-CSF, WBR, RT, Temodar, B-RAF negative, SRS (Novalis) to brain, Breast mets (Mastectomy), currently on Ipilimumab compassionate use trial
Mets to brain, lung and sub-qs. Craniotomy.

Rocklove - (9/14/2010 - 5:47am)

Katy I was on the oncovex YM155  trial in Jan 2010 and was on it 6 weeks. Did ct scans and the mel progressed. Dr. Weber  @ Moffit immediatly put me in the bio-chemo. Oncovex-YM155 did not work for me. I hope you have good luck with what ever choice you make.

Prayers & Positive Thoughts for You and Family

Rocky (Stage IV Liver Mets)

mimi0201 - (9/14/2010 - 11:52am)

     My husband is curently enrolled in the Oncovex trial at Rush in Chicago.  He's been on it since May and has 2 out of 3 subQ tumors disappear completely, one shrank 50%.  He had a CT at 3 months and it showed a  new small tumor in his right lung.  The other disease that he had had either regressed ot stayed the same.  He's stage IV, with multiple mets.  He has seen an increase in his energy level, and feels really pretty well.  His MRI at 4 months was just done Monday and is thankfully clean.  Dr Kaufman is not too concerned about the new lung met.  He feels that it will regress/die before the next scans at 6 months.  The treatment is very tolerable.  Slight side effects of fever, chills for 4-6 hours after injections, with  side effects getting less and the treatment progresses along.  We were going to withdraw from the trial if we did not get in the Oncovex arm.  2/3's get it, 1/3 only GSM-CSF.  We have met several of the trial participants, some with successful response, others no response.  We are very pleased with Rush, the staff and nurses along with Dr Kaufman.  Feel free to contact me.  Good luck.

KatyWI - (9/14/2010 - 11:54am)

So far I've found this out...

It's not a crossover design.  (Some argue that the crossover design was a flaw with the phase III study that resulted in the approval of interferon, but it does make patients less worried about getting the control arm.)

The head nurse could not find any data on use of GM-CSF (the control) in patients with active metastatic disease, but she does say it is being used by people.  She's asked the research librarian to search and will get back to me.

The first re-scan is at 8 weeks, so if there is progression on the control arm at that point I'd be off study and could pursue something else.  On the trial arm they want you to stay on for 24 weeks to allow for a delayed immune-based response, similar to what's seen with Ipi.  But it's up to the individual & his/her doctor.

I am astonished that the ethics review boards allowed GM-CSF to be the control arm.  It's as if they're doing a phase II study on GM-CSF inside of this phase III study on Oncovex.  All anybody's been able to cite for me so far is theory on how GM-CSF could work against active disease.  Phase III trials are supposed to be comparisons against standard treatment.  [Rant over, for now.]

I am still leaning towards doing the trial.  I'm trying to gauge the risk of getting GM-CSF against the potential benefit of getting Oncovex.  1/3 get GM-CSF and 2/3 get Oncovex.  I have a little time to decide because the Milwaukee trial site isn't open yet.

Thanks for the info, everybody.

KatyWI

Just keep going!

killmel - (9/14/2010 - 12:18pm)

Hi Katy,

 

For what is is worth, Gm-CSF did not work for me. while on it, I had recurrences.Good Luck with your decision.

jag - (9/14/2010 - 12:26pm)

Katy, I have heard good things about the Oncovex trial. Here would be my strategy.

1.  Go ahead with the trial.

2. Definitely drop out if you get the GMCSF arm, that is bullshit.

3.  While IL2 didn't work, it may be due to the fact that your immune system wasn't primed to go after your particular melanoma.  If Oncovex gives you a custom vaccine for melanoma, the compounded effect with another immunostimulant such as ipilimumab may do the job in the future. 

Insert Generic Inspirational Motto Here

Anonymous - (9/14/2010 - 12:45pm)

Katy,

 

Here are some study results on Gm-CSF presented at Asco 2010:

E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma.

This is an ECOG study begun in 2006 to see if SQ GM-CSF is an effective adjuvant treatment in patients with resectable metastatic disease, after surgery. The primary endpoint was overall survival which at the time of the abstract’s writing (updates for ASCO are suggested in the text) was NOT met, meaning that overall the drug was not effective. PFS (progression free survival) was positive statistically but only 3 months difference.

full abstract link:
http://abstract.asco.org/AbstView_74_49374.html

Here is another website maintained by Eric Whitman a melanoma expert at Atlantic Melanoma Center:

E4697: Phase III cooperative group study of yeast-derived granulocyte macrophage colony-stimulating factor (GM-CSF) versus placebo as adjuvant treatment of patients with completely resected stage III-IV melanoma.

The updated data for this trial was all negative. There were no significant results except for a very small subgroup of patients with Stage IV melanoma. Everybody was pretty negative.

 

Hope this helps you decide to go on Gm-CSF