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8th round of ipi, question to end the trial

Forums General Melanoma Community 8th round of ipi, question to end the trial

  • Post
    swissie
    Participant

      I haven't really posted on this new forum, but now I need some help.

      I was diagnosed with melanoma in September 2008 (1.4 mm), with a "negative" SNB. I found a macrometatastase in June 2009. Of the 12 nodes, 3 had cancer, one of which was outside of the node.

      I haven't really posted on this new forum, but now I need some help.

      I was diagnosed with melanoma in September 2008 (1.4 mm), with a "negative" SNB. I found a macrometatastase in June 2009. Of the 12 nodes, 3 had cancer, one of which was outside of the node.

      In September 2009 I started a double blind trial with ipilimumab (10 mg/kg), after my 4th infusion I had a colitis and knew I am in the ipi arm of the trial.
      I had my 8th round of ipi two weeks ago!

      Since I started I had headaches, itching, a funny Beau's line on my toe nales, a colitis (after 4th infusion; min grade 3), a rash  (a week BEFORE my 8th! infusion; min grade 3).
      My doctor does not believe the rash was ipi related, but for me it looks exactly the same as some examples I saw in recent articles on CTLA-4 side effects.
      Also I have a Barret Espohagus, which again is a coincidence according to my doctor (although I never experienced heartburn of reflux before my trial, and although anti-reflux medication doesn't seem to work).

      At the moment, my biggest problem is exhaustion.

      My first question is if there are others like me out there who had 8 rounds of ipi or more? How are you feeling? Any new side effects?

      My second question is if I should quit the trial. It seems to be taking it's toll. Being exhausted all the time sucks big time. I was very tired from the beginning, but it's getting worse every round.
      The extreme rash was only a week before my 8th infusion, so I seem to have late responses.

      Any smart ideas?

      Thanks,
      Sabine
       

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    • Replies
        Jerry from Cape Cod
        Participant

          Hi Swissie,

          I'm heading into week 96 next week (12th infusion).  About 6 months into the treatment a blood test revealed that my thyroid levels had dropped significantly.  This is a fairly rare side effect.  It took about 4 months of med adjustment and additon of testosterone for me but my energy level had a significant improvement.

          The last blood test showed a shift in Thyroid again and I'm currently feeling the fatigue return so I expect to see confirmation in the blood tests and a change in the Thyroid replacement again.

          My rash has returned to a level 6-7 out of ten.  It was significantly less for the last 10 months.  Seems to be building up again.

          I haven't had severe GI problems but they have increased slightly in the last 6 months.

          My Vitiglo patches have expended in the last 4 months after a period of stability.

          I'm hopeful that the scans this week will show additional reduction in the remaining mets as I know you are.

          Has your doctor been monitoring your Thyroid function? 

          Also, I've been told that the have been patients who have reported varying degrees of side effects throughout the protocol.

          Best wishes for good scans.

          Jerry from Cape Cod

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          Jerry from Cape Cod
          Participant

            Hi Swissie,

            I'm heading into week 96 next week (12th infusion).  About 6 months into the treatment a blood test revealed that my thyroid levels had dropped significantly.  This is a fairly rare side effect.  It took about 4 months of med adjustment and additon of testosterone for me but my energy level had a significant improvement.

            The last blood test showed a shift in Thyroid again and I'm currently feeling the fatigue return so I expect to see confirmation in the blood tests and a change in the Thyroid replacement again.

            My rash has returned to a level 6-7 out of ten.  It was significantly less for the last 10 months.  Seems to be building up again.

            I haven't had severe GI problems but they have increased slightly in the last 6 months.

            My Vitiglo patches have expended in the last 4 months after a period of stability.

            I'm hopeful that the scans this week will show additional reduction in the remaining mets as I know you are.

            Has your doctor been monitoring your Thyroid function? 

            Also, I've been told that the have been patients who have reported varying degrees of side effects throughout the protocol.

            Best wishes for good scans.

            Jerry from Cape Cod

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            Jim in Denver
            Participant

              Hi Sabine,

              Jerry has been at this a lot longer than I have, but here is my response.  I have had 5 rounds since early August, and have not had issue with fatigue except very mild for a couple of days after infusion.  As you should know, side effects vary considerably from person to person, and can change over time as well.  My main issue is a sever rash that itches like crazy, especially at night when I an trying to go to sleep.  My wife isn't happy abou the situation either, but it is s sign that my immune system is cranked up and going after the mel, so I can live with it.

              Fatigue can be a big issue, which it seems to be for you.  The esopageal situation is a new one to me, so I have no insight there.  As for quitting the trial, you have to weigh the pros and cons carefully.  You are asking whether the side effects will be less over time.  From what I understand, nobody can really answer that for you.  Another question is whether side effects will be less if you stopped the Ipi treatment – there is not guarantee on that either.  Kinda "damned if you do, damned oif you don't" type situation perhaps.  What I can tell you is that most of the thousand or so people who have ever received this drug in trials and are still alive have chosen to continue treatment if they are eligible because it has worked tfor them and they do not want to stop – this info is from my Oncologist.

              If you quit, the efffects on your immume sustem, both positive and negative, will persist for some time – maybe 6 months or more.  It has been shown that if a person responds to Ipi initially, then they will also respond to a resumption of treatment after stopping ("reinduction").  So if you stop and tumors develop later, then presumably you can start Ipi again (assuming it is approved by then and you can get someone to pay for it at around $5000 per infusion – the Swiss government or insurance maybe?).  Ipi (Yervoy) will at some point be approved in the US and Europe, perhaps as ealy as next March in the US.  Cost may be an issue for some people, so access may not be equal for all patients who need the treatment.

              No easy answers, maybe, but make your list of pros and cons and good luck with your decison,  Hope this helps a little.

              Best Wishes,

              Jim

               

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              Jim in Denver
              Participant

                Hi Sabine,

                Jerry has been at this a lot longer than I have, but here is my response.  I have had 5 rounds since early August, and have not had issue with fatigue except very mild for a couple of days after infusion.  As you should know, side effects vary considerably from person to person, and can change over time as well.  My main issue is a sever rash that itches like crazy, especially at night when I an trying to go to sleep.  My wife isn't happy abou the situation either, but it is s sign that my immune system is cranked up and going after the mel, so I can live with it.

                Fatigue can be a big issue, which it seems to be for you.  The esopageal situation is a new one to me, so I have no insight there.  As for quitting the trial, you have to weigh the pros and cons carefully.  You are asking whether the side effects will be less over time.  From what I understand, nobody can really answer that for you.  Another question is whether side effects will be less if you stopped the Ipi treatment – there is not guarantee on that either.  Kinda "damned if you do, damned oif you don't" type situation perhaps.  What I can tell you is that most of the thousand or so people who have ever received this drug in trials and are still alive have chosen to continue treatment if they are eligible because it has worked tfor them and they do not want to stop – this info is from my Oncologist.

                If you quit, the efffects on your immume sustem, both positive and negative, will persist for some time – maybe 6 months or more.  It has been shown that if a person responds to Ipi initially, then they will also respond to a resumption of treatment after stopping ("reinduction").  So if you stop and tumors develop later, then presumably you can start Ipi again (assuming it is approved by then and you can get someone to pay for it at around $5000 per infusion – the Swiss government or insurance maybe?).  Ipi (Yervoy) will at some point be approved in the US and Europe, perhaps as ealy as next March in the US.  Cost may be an issue for some people, so access may not be equal for all patients who need the treatment.

                No easy answers, maybe, but make your list of pros and cons and good luck with your decison,  Hope this helps a little.

                Best Wishes,

                Jim

                 

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                swissie
                Participant

                  Thank you for the reply's.

                  Jerry, good luck with your scans. I hope with you that all is fine!
                  Yes, my TSH and FT4 are checked, and my TSH has been a bit high from the beginning. It increased from 6.5 (upper range 4.25) to 7.5 so that's not dramatic. My FT4 has always been within the range.
                  So I guess these values are not high enough to make me feel this tired.

                  Jim, yes I agree that it might take some time anyway to get rid of the side effects. Actually my health insurance in Switzerland is quite good, so I guess I could get the medication later if it is approved. And worste case we'll manage to pay for a few shots ourselves, if that's what would be needed.

                  You say that around 1000 people are still alive. I would like to know how many infusions and which volume these patients actually got.
                  I knew Jerry was almost a year longer in the trial, and I believe there are some more people who had more shots.
                  But I think some people had to stop earlier due to side effects.

                  Anyway, you are right, I do have to make an overview fo the pro's and con's and make a decision. Luckily I still have some time, my next shot is only in 2.5 months.

                  Best Wishes,
                  Sabine

                   

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                  swissie
                  Participant

                    Thank you for the reply's.

                    Jerry, good luck with your scans. I hope with you that all is fine!
                    Yes, my TSH and FT4 are checked, and my TSH has been a bit high from the beginning. It increased from 6.5 (upper range 4.25) to 7.5 so that's not dramatic. My FT4 has always been within the range.
                    So I guess these values are not high enough to make me feel this tired.

                    Jim, yes I agree that it might take some time anyway to get rid of the side effects. Actually my health insurance in Switzerland is quite good, so I guess I could get the medication later if it is approved. And worste case we'll manage to pay for a few shots ourselves, if that's what would be needed.

                    You say that around 1000 people are still alive. I would like to know how many infusions and which volume these patients actually got.
                    I knew Jerry was almost a year longer in the trial, and I believe there are some more people who had more shots.
                    But I think some people had to stop earlier due to side effects.

                    Anyway, you are right, I do have to make an overview fo the pro's and con's and make a decision. Luckily I still have some time, my next shot is only in 2.5 months.

                    Best Wishes,
                    Sabine

                     

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