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Stage IIIC questions about clinical trials

Forums General Melanoma Community Stage IIIC questions about clinical trials

  • Post
    Janis B.
    Participant

    Hello all,

    Hello all,

    For over a year I've read this board and have learned so much, especially about hope and courage.  Now it's time for me to jump in, so I hope someone is out there listening.  My brief history – I was dx'd in 08 at Level IB, had WLE and SNB – no mets.  Recurrance 1 yr. later – three tumors in same area.  Isolated Limb perfusion tried and failed, followed by 2nd WLE and SNB.  Micromets to one lymph node.  Node dissection w/ no further cancer found.  Began interferon late 09, completed induction phase, unbalbe to contue maintenance phase because I got too ill.  Soooo – I'm now IIIC, NED since 2/10.

    My question – my dr. at MDA seems to be saying that, with no active tumors, I'll be eligible for clinical trials if/when I progress to Stage IV.  Is melanoma a wait and see game? (sorry to use that word – this is so serious for all of us).  I'm BRAF pos.  Are the new BRAF trials just for those with active disease??  Is there nothing that will stay the beast?  Of course, I'm very very grateful to be free of the disease for these past months, but is there anything for Stage IIIC and holding?

    I will be so grateful for any answers.

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  • Replies
      bill58
      Participant

      I was Stage IIIC earlier this year and could not get into any of the trials my doctor had unless I had active disease.

      You sholuld make sure you are tested for all of the variousthings like Braf, HLA-A2, CKIT/MKE(dont know much about that one) so you are ready if things progress.  I guess if you dont have any current disease, the clinical trials cannot show progression or reduction in your disease.

      As hard as it is, sometimes waiting and watching while NED can be a good thing.  Try to keep positive and enjoy life each and every day.

      Bill

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      bill58
      Participant

      I was Stage IIIC earlier this year and could not get into any of the trials my doctor had unless I had active disease.

      You sholuld make sure you are tested for all of the variousthings like Braf, HLA-A2, CKIT/MKE(dont know much about that one) so you are ready if things progress.  I guess if you dont have any current disease, the clinical trials cannot show progression or reduction in your disease.

      As hard as it is, sometimes waiting and watching while NED can be a good thing.  Try to keep positive and enjoy life each and every day.

      Bill

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      KatyWI
      Participant

      Hi Janis,

      First, HAPPY HAPPY that you're NED! 

      But to address your question, I'm not immediately aware of any trials that would be open to you.  There is a trial of ipi vs. placebo for fully-resected stage III patients, but your ILP and interferon would exclude you from that one.  (I just looked up the trial here:  http://www.clinicaltrials.gov/ct2/show/NCT00636168?term=melanoma+ipilimumab&recr=Open&rank=3)

      Watch-and-wait gets less scary as time goes on.  You might recur, but then again, you might not!  If you've learned anything this past year, it's that melanoma is unpredictable and does whatever the hell it wants.  I'm hoping for you that it "wants" to crawl into a hole and stay there!

      KatyWI

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      KatyWI
      Participant

      Hi Janis,

      First, HAPPY HAPPY that you're NED! 

      But to address your question, I'm not immediately aware of any trials that would be open to you.  There is a trial of ipi vs. placebo for fully-resected stage III patients, but your ILP and interferon would exclude you from that one.  (I just looked up the trial here:  http://www.clinicaltrials.gov/ct2/show/NCT00636168?term=melanoma+ipilimumab&recr=Open&rank=3)

      Watch-and-wait gets less scary as time goes on.  You might recur, but then again, you might not!  If you've learned anything this past year, it's that melanoma is unpredictable and does whatever the hell it wants.  I'm hoping for you that it "wants" to crawl into a hole and stay there!

      KatyWI

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      Jerry from Cape Cod
      Participant

      Virtually all trials are conducted on Stage IV patients for a number of reasons.  Some of which are:

      * It's easier and faster to measure results in a patient with known disease.
      * There are few options other than trials and surgery for Stage IV patients.
      * Trial protocols and trial drugs are expensive and if the companies increased the range of trials the end cost of the
         approval would be prohibitive. If it sounds crass and commercial it is, but it's still the best system in the world.

      Right now Melanoma is basically a wait and see situation.  Typically after trial drugs are approved there will be trials or offerings to lower stage patients and the results will be then reviewed to see if the long term results are as expected.

      An interesting side note that I learned a couple of weeks ago about clinical trials in all cancers.  Only 3% of ALL cancer patients participate in clinical trials.  When limited only to melanoma patients the number is significantly higher especially at stage IV as most consider the "standard of care" at stage IV to be clinical trials.

      Stage IIIC and holding is a good thing.  You will find many here who have been that for years ongoing.  You will also notice that after a period of time those who are stable or NED for a siginificant time tend to drift away from the forums as melnaoma worries become less of their daily concerns.  That's such a good thing.

      Jerry from Cape Cod
      Stage IV – Ipi week 91 but who's counting

       

       

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        Jerry from Cape Cod
        Participant

        The other reason for not using trial meds at lower stage is part of the "Hipocratic Oath" to "abstain from whatever is harmful or mischievous." or "do no harm."  Many trial medications have very serious side effects and the unknown benefits have to be weighed against the unknown possibility of benefit.

        Now this is interesting in itself as there are many interpertations of the "Hipocratic Oath" and many re-writes and updates.The AMA does not providid or subscribe to a version themselves but they have a "Code of Ethics." Interestingly according to quick internet research it is maintained that some medical schools to do not subscribe to ANY oath upon graduation.

        While there is no clear version of the "Hipocratic Oath" that starts with the commonly heard "FIRST, Do no harm" in all versions and modernizations there are phrases of similar intent and other codes of ethics seem to support the same message.

        Jerry from Cape Cod

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        Jerry from Cape Cod
        Participant

        The other reason for not using trial meds at lower stage is part of the "Hipocratic Oath" to "abstain from whatever is harmful or mischievous." or "do no harm."  Many trial medications have very serious side effects and the unknown benefits have to be weighed against the unknown possibility of benefit.

        Now this is interesting in itself as there are many interpertations of the "Hipocratic Oath" and many re-writes and updates.The AMA does not providid or subscribe to a version themselves but they have a "Code of Ethics." Interestingly according to quick internet research it is maintained that some medical schools to do not subscribe to ANY oath upon graduation.

        While there is no clear version of the "Hipocratic Oath" that starts with the commonly heard "FIRST, Do no harm" in all versions and modernizations there are phrases of similar intent and other codes of ethics seem to support the same message.

        Jerry from Cape Cod

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      Jerry from Cape Cod
      Participant

      Virtually all trials are conducted on Stage IV patients for a number of reasons.  Some of which are:

      * It's easier and faster to measure results in a patient with known disease.
      * There are few options other than trials and surgery for Stage IV patients.
      * Trial protocols and trial drugs are expensive and if the companies increased the range of trials the end cost of the
         approval would be prohibitive. If it sounds crass and commercial it is, but it's still the best system in the world.

      Right now Melanoma is basically a wait and see situation.  Typically after trial drugs are approved there will be trials or offerings to lower stage patients and the results will be then reviewed to see if the long term results are as expected.

      An interesting side note that I learned a couple of weeks ago about clinical trials in all cancers.  Only 3% of ALL cancer patients participate in clinical trials.  When limited only to melanoma patients the number is significantly higher especially at stage IV as most consider the "standard of care" at stage IV to be clinical trials.

      Stage IIIC and holding is a good thing.  You will find many here who have been that for years ongoing.  You will also notice that after a period of time those who are stable or NED for a siginificant time tend to drift away from the forums as melnaoma worries become less of their daily concerns.  That's such a good thing.

      Jerry from Cape Cod
      Stage IV – Ipi week 91 but who's counting

       

       

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      lhaley
      Participant

      Janis,

      It's hard to get used to, but many of us are on watch and wait. Even when stage IV if there is no active disease there are very limited choices. The only one I know of is with a vaccine and you have to have a specific hla factor.  With you being at MDA I would think they would have an option for you if there was one out there.

      Remember that a trial is not proven. The thought process is that if you do not have active disease how would they know if the trial drug was working. Plus, you have a good chance of going through many side effects without the knowledge if it's doing you personally any good.

      I went to Stage IV 4.5 years ago. Did a trial with gmcsf for a year but recurred. Since then I have had a few more recurrances that have been surgically resected. This time they are checking me for the B-raf mutation. Just remember that they are making bigger strides now in melanoma than they ever have before. Hopefully you will never need those drugs, meanwhile keep educated, mindful of any changes in your body, and keep on living.

      Linda

      NED 3 weeks today!

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      lhaley
      Participant

      Janis,

      It's hard to get used to, but many of us are on watch and wait. Even when stage IV if there is no active disease there are very limited choices. The only one I know of is with a vaccine and you have to have a specific hla factor.  With you being at MDA I would think they would have an option for you if there was one out there.

      Remember that a trial is not proven. The thought process is that if you do not have active disease how would they know if the trial drug was working. Plus, you have a good chance of going through many side effects without the knowledge if it's doing you personally any good.

      I went to Stage IV 4.5 years ago. Did a trial with gmcsf for a year but recurred. Since then I have had a few more recurrances that have been surgically resected. This time they are checking me for the B-raf mutation. Just remember that they are making bigger strides now in melanoma than they ever have before. Hopefully you will never need those drugs, meanwhile keep educated, mindful of any changes in your body, and keep on living.

      Linda

      NED 3 weeks today!

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      lovingwifedeb
      Participant
      I understand your frustration, been there, done that. My husband did qualify for a cancer vaccine trial but there also was a chance of a placebo given… Who needs that?

      So, while my husband “waits” he has decided to help out his immune system by changing his diet… Eating better. Reading all abot what his enemy hates… How else does one do battle? I am his first leutenient, his protector and I will do anything I can to help win this war!

      Deb
      lovingwife to Bob, stage 3c

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      lovingwifedeb
      Participant
      I understand your frustration, been there, done that. My husband did qualify for a cancer vaccine trial but there also was a chance of a placebo given… Who needs that?

      So, while my husband “waits” he has decided to help out his immune system by changing his diet… Eating better. Reading all abot what his enemy hates… How else does one do battle? I am his first leutenient, his protector and I will do anything I can to help win this war!

      Deb
      lovingwife to Bob, stage 3c

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      Janis B.
      Participant

      To all of you who replied,

      Today I sighed a big sigh of relief, first of all for the info and then because you have all been in this boat and understand those conflicting feelings of –  I have melanoma!  but I'm alive and still feel good!!  The whys and hows of clinical trials should have been common sense for me, but the info out there is overwhelming and hard to condense without a little help from mm friend- in-kind.

      Thanks for the words of support, reminders to stay positive and work against those "enemies" of cancer in the diet.  Jerry, the Hippocratic Oath research – very interesting!

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      Janis B.
      Participant

      To all of you who replied,

      Today I sighed a big sigh of relief, first of all for the info and then because you have all been in this boat and understand those conflicting feelings of –  I have melanoma!  but I'm alive and still feel good!!  The whys and hows of clinical trials should have been common sense for me, but the info out there is overwhelming and hard to condense without a little help from mm friend- in-kind.

      Thanks for the words of support, reminders to stay positive and work against those "enemies" of cancer in the diet.  Jerry, the Hippocratic Oath research – very interesting!

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      Jim M.
      Participant

      Hi Janis,

       I and a few others must be part of a minority as I was on a clinical trial at stage 3C resected melanoma. I decided against Interferon and watching and waiting. At that time Moffitt (Tampa, Fl.) was offering Ipilimumab with or without peptide vaccines for stages 3 and 4 (resected or not). I chose the clinical trial. My onc, Dr. Jeffrey Weber, is one of the top immunologists in the U.S. and he answers emails. You don't have to be his patient. If you send him an email early morning on a weekday you are likely to get a response from him the same day. He may know about other trials that you would qualify for. Dr. Weber's email is: [email protected]

       Best of success and God Bless,

       Jim M.

       Stage 3C

       NED 3 years

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      Jim M.
      Participant

      Hi Janis,

       I and a few others must be part of a minority as I was on a clinical trial at stage 3C resected melanoma. I decided against Interferon and watching and waiting. At that time Moffitt (Tampa, Fl.) was offering Ipilimumab with or without peptide vaccines for stages 3 and 4 (resected or not). I chose the clinical trial. My onc, Dr. Jeffrey Weber, is one of the top immunologists in the U.S. and he answers emails. You don't have to be his patient. If you send him an email early morning on a weekday you are likely to get a response from him the same day. He may know about other trials that you would qualify for. Dr. Weber's email is: [email protected]

       Best of success and God Bless,

       Jim M.

       Stage 3C

       NED 3 years

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