Feedback on trials being offered

This topic has 24 replies, 7 voices, and was last updated 13 years ago by shellebrownies.

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- May 8, 2011 at 12:07 am
- Quote
shellebrownies
Participant
My husband Don was given info on three trials he might qualify for if he doesn't have brain mets. We've started reading through the packets, but it's kind of mind-boggling right now.

I was wondering if anyone has been on or has any good information on the following trials:

BRAF/MEK

Ipi with Bevacizumab

Ipi with GM-CSF

I appreciate any feedback, experiences, or information you can provide. Thank you!

My husband Don was given info on three trials he might qualify for if he doesn't have brain mets. We've started reading through the packets, but it's kind of mind-boggling right now.

I was wondering if anyone has been on or has any good information on the following trials:

BRAF/MEK

Ipi with Bevacizumab

Ipi with GM-CSF

I appreciate any feedback, experiences, or information you can provide. Thank you!

Viewing 5 reply threads

Replies

- - May 8, 2011 at 9:36 am
  - Quote
  FormerCaregiver
  Participant
  I think that the ipi with GM-CSF trial is probably the best of the 3. Is the following the trial
  that you are considering?
  http://www.clinicaltrials.gov/ct2/show/NCT01134614?term=GM-CSF+melanoma+boston&rank=2
  
  It would be interesting to see if one could have GM-CSF independently from other drugs. Lately, I
  have noticed that a lot of stage IV patients who have had GM-CSF are able to keep melanoma at bay
  for very long periods of time.
  
  Frank from Australia
  - May 9, 2011 at 4:26 am
    
    Quote
    Janis B.
    Participant
    
    I'm in an OncoVex trial, with GM CSF alone as the control drug. The research nurse told me that GM CSF trials ended at Phase II and it appears to be used only as a control drug in melanoma trials now. The FDA clinical trial website reports no final results for any of the GM CSF trials, which can be due to a number of factors that are listed on the site.
  - May 9, 2011 at 3:42 pm
    
    Quote
    boot2aboot
    Participant
    
    Janis,
    
    How is that Oncovex withGM-CSFworking out??? i am really looking into this for my treatment
    
    boots
  - May 9, 2011 at 3:42 pm
    
    Quote
    boot2aboot
    Participant
    
    Janis,
    
    How is that Oncovex withGM-CSFworking out??? i am really looking into this for my treatment
    
    boots
  - May 10, 2011 at 2:58 am
    
    Quote
    Janis B.
    Participant
    
    Just started last week. As the trial progresses, hopefully my new tumor will shrink and disappear! One thing I can confirm – after interferon, the side effects (2 days of flu-like symptoms) are a piece of cake, a walk in the park. Fell free to e-mail me if you have any questions!
  - May 10, 2011 at 2:58 am
    
    Quote
    Janis B.
    Participant
    
    Just started last week. As the trial progresses, hopefully my new tumor will shrink and disappear! One thing I can confirm – after interferon, the side effects (2 days of flu-like symptoms) are a piece of cake, a walk in the park. Fell free to e-mail me if you have any questions!
  - May 10, 2011 at 2:30 pm
    
    Quote
    shellebrownies
    Participant
    
    Janis,
    
    I was just looking at that trial, but my husband would be excluded because he has bone metastases…
  - May 10, 2011 at 2:30 pm
    
    Quote
    shellebrownies
    Participant
    
    Janis,
    
    I was just looking at that trial, but my husband would be excluded because he has bone metastases…
  - May 9, 2011 at 4:26 am
    
    Quote
    Janis B.
    Participant
    
    I'm in an OncoVex trial, with GM CSF alone as the control drug. The research nurse told me that GM CSF trials ended at Phase II and it appears to be used only as a control drug in melanoma trials now. The FDA clinical trial website reports no final results for any of the GM CSF trials, which can be due to a number of factors that are listed on the site.
  - May 10, 2011 at 1:58 pm
    
    Quote
    shellebrownies
    Participant
    
    Yes, Frank, that is one of the trials Don has been offered. The issue is that only half of the patients will actually recieve the GM-CSF with the Ipi. The other half only receive the Ipi. Not sure if those are chances we want to take considering how quickly the mel seems to be spreading.
    
    However, it still looks better than the other Ipi trial. I'm still trying to read through the BRAF MEK paperwork to make more sense out of it…
  - May 10, 2011 at 2:24 pm
    
    Quote
    dawn dion
    Participant
    
    When I was doing ipi I believe I was told that was no placebo for stage IV. I could be wrong but I think I remember hearing that. As far as BRAF/MEK goes I am currently on this trial – from my experiences and from the information I have gotten at Moffitt it is a great trial. Even though I was told that the information on the trial was written for a 6th grader to understand I found it very taxing trying to wade through it.
  - May 10, 2011 at 2:32 pm
    
    Quote
    shellebrownies
    Participant
    
    Dawn,
    
    That's good to know that this trial is showing success. I thought I'd heard somewhere (perhaps my onco) that it has about an 80% positive response rate for varying lengths of time. Now to find out whether he's BRAF positive or not! 🙂
  - May 10, 2011 at 2:32 pm
    
    Quote
    shellebrownies
    Participant
    
    Dawn,
    
    That's good to know that this trial is showing success. I thought I'd heard somewhere (perhaps my onco) that it has about an 80% positive response rate for varying lengths of time. Now to find out whether he's BRAF positive or not! 🙂
  - May 10, 2011 at 2:24 pm
    
    Quote
    dawn dion
    Participant
    
    When I was doing ipi I believe I was told that was no placebo for stage IV. I could be wrong but I think I remember hearing that. As far as BRAF/MEK goes I am currently on this trial – from my experiences and from the information I have gotten at Moffitt it is a great trial. Even though I was told that the information on the trial was written for a 6th grader to understand I found it very taxing trying to wade through it.
  - May 10, 2011 at 1:58 pm
    
    Quote
    shellebrownies
    Participant
    
    Yes, Frank, that is one of the trials Don has been offered. The issue is that only half of the patients will actually recieve the GM-CSF with the Ipi. The other half only receive the Ipi. Not sure if those are chances we want to take considering how quickly the mel seems to be spreading.
    
    However, it still looks better than the other Ipi trial. I'm still trying to read through the BRAF MEK paperwork to make more sense out of it…
- - May 8, 2011 at 9:36 am
  - Quote
  FormerCaregiver
  Participant
  I think that the ipi with GM-CSF trial is probably the best of the 3. Is the following the trial
  that you are considering?
  http://www.clinicaltrials.gov/ct2/show/NCT01134614?term=GM-CSF+melanoma+boston&rank=2
  
  It would be interesting to see if one could have GM-CSF independently from other drugs. Lately, I
  have noticed that a lot of stage IV patients who have had GM-CSF are able to keep melanoma at bay
  for very long periods of time.
  
  Frank from Australia
- - May 9, 2011 at 4:44 am
  - Quote
  washoegal
  Participant
  My question would be what is the control arm of the trial. If any of them offer a second drug as the control arm I would go for that one rather than a placebo.
- - May 9, 2011 at 4:44 am
  - Quote
  washoegal
  Participant
  My question would be what is the control arm of the trial. If any of them offer a second drug as the control arm I would go for that one rather than a placebo.
  - May 10, 2011 at 1:53 pm
    
    Quote
    shellebrownies
    Participant
    
    On the BRAF-MEK, the BRAF only is the control; the other two arms are BRAF-MEK in differing doses.
    
    The Ipi-GM-CSF is randomized 2 arms, one being ipi alone and one being ipi with GM-CSF.
    
    The Ipi-Bev trial everyone gets both meds, but at varying doses.
    
    So, none of them have a placebo control, which is good.
  - May 10, 2011 at 1:53 pm
    
    Quote
    shellebrownies
    Participant
    
    On the BRAF-MEK, the BRAF only is the control; the other two arms are BRAF-MEK in differing doses.
    
    The Ipi-GM-CSF is randomized 2 arms, one being ipi alone and one being ipi with GM-CSF.
    
    The Ipi-Bev trial everyone gets both meds, but at varying doses.
    
    So, none of them have a placebo control, which is good.
- - May 11, 2011 at 6:32 pm
  - Quote
  rbruce
  Participant
  Has your Oncologist determined his specific mutation yet? Is he BRAF positive? BRAF + is about 60-70% of melanoma cases. I was hoping for a BRAF trial of the new "inhibitor drugs" which are showing good results in UCSF's trial, but found out recently that I am not BRAF + but instead "wild type" NRAS+ (about 20% of melanomas) so I'm back to square one looking for a trial. Keep the faith, everyday something new is coming along after 13 years of NO new melanoma drugs. God bless. Robert
  - May 11, 2011 at 7:52 pm
    
    Quote
    shellebrownies
    Participant
    
    rbruce,
    
    Don had a biopsy of one of the liver lesions today so they can confirm Stage IV (for the trials, they already know he is) and check for BRAF mutation. Apparently the sample from his original tumor was not prepared properly and could not be accurately tested for the mutation (rolls eyes at local hospital).
    
    As for you, if you are willing to travel in to San Fran, here is a trial actively recruiting that you may want to look into if you haven't already:
    
    Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma http://www.clinicaltrials.gov/ct2/show/study/NCT00769704term=melanoma&recr=Open&state1=NA%3AUS%3ACA&rank=1&show_locs=Y#locn
    
    Thanks again for your response, and best of luck with finding a trial.
    
    Michelle
  - May 11, 2011 at 7:52 pm
    
    Quote
    shellebrownies
    Participant
    
    rbruce,
    
    Don had a biopsy of one of the liver lesions today so they can confirm Stage IV (for the trials, they already know he is) and check for BRAF mutation. Apparently the sample from his original tumor was not prepared properly and could not be accurately tested for the mutation (rolls eyes at local hospital).
    
    As for you, if you are willing to travel in to San Fran, here is a trial actively recruiting that you may want to look into if you haven't already:
    
    Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma http://www.clinicaltrials.gov/ct2/show/study/NCT00769704term=melanoma&recr=Open&state1=NA%3AUS%3ACA&rank=1&show_locs=Y#locn
    
    Thanks again for your response, and best of luck with finding a trial.
    
    Michelle
- - May 11, 2011 at 6:32 pm
  - Quote
  rbruce
  Participant
  Has your Oncologist determined his specific mutation yet? Is he BRAF positive? BRAF + is about 60-70% of melanoma cases. I was hoping for a BRAF trial of the new "inhibitor drugs" which are showing good results in UCSF's trial, but found out recently that I am not BRAF + but instead "wild type" NRAS+ (about 20% of melanomas) so I'm back to square one looking for a trial. Keep the faith, everyday something new is coming along after 13 years of NO new melanoma drugs. God bless. Robert