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IPI questions

Forums General Melanoma Community IPI questions

  • Post
    s Mom
    Participant

      Thank you for your kind replies on my previous post about my son's treatment options.   So many of your stories are heroic and inspirational, and I hope that a cure will soon be found for this awful disease.  

      Thank you for your kind replies on my previous post about my son's treatment options.   So many of your stories are heroic and inspirational, and I hope that a cure will soon be found for this awful disease.  

      My questions deal with IPI –  I've read that it will soon be approved by the FDA.  Any information on when??  Also, will it be used for all stages of melanoma?  Has it been shown to stop recurrence with only unresected tumor growth?  Any information would certainly be welcome as we are looking into a possible IPI clinical trial with (unfortunately) a placebo arm.

      Thanks!

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        jim Breitfeller
        Participant

          Rumor on the street says March 26 FDA approval

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          jim Breitfeller
          Participant

            Rumor on the street says March 26 FDA approval

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            Tim–MRF
            Guest

              The FDA has said they will make a decision by March 26.  Since that is a Saturday, the announcement will likely come between now and 5:00 Eastern on Friday.  It is widely expected that they will grant approval.  Hard to imagine that they won't, particularly since they cancelled the public hearing on the issue.

              Just yesterday the company issued a press release saying that a new study, using ipi as a first line of therapy for Stage IV and Stage III unresectable patients, has demonstrated overall survival benefit.  This is great news and is reason to expand the use of ipi beyond the second and third-line therapy that was the practice in earlier trials.

              Tim–MRF

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              Tim–MRF
              Guest

                The FDA has said they will make a decision by March 26.  Since that is a Saturday, the announcement will likely come between now and 5:00 Eastern on Friday.  It is widely expected that they will grant approval.  Hard to imagine that they won't, particularly since they cancelled the public hearing on the issue.

                Just yesterday the company issued a press release saying that a new study, using ipi as a first line of therapy for Stage IV and Stage III unresectable patients, has demonstrated overall survival benefit.  This is great news and is reason to expand the use of ipi beyond the second and third-line therapy that was the practice in earlier trials.

                Tim–MRF

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                KatyWI
                Participant

                  I don't think any early results have been posted yet on the ipi stage III trial – so nobody knows if it will stop recurrence.  You could double check with the doctor who'd be running the trial.

                  I did see a new trial (which is unfortunately not yet recruiting) that compares ipi to interferon for stage III/resected.  That might be a little less "scary" than the trial with a placebo arm.  I hope this link works:

                  http://www.clinicaltrials.gov/ct2/show/NCT01274338?term=ipilimumab&recr=Open&rank=6

                  Good luck to you both – I'm 36 (first dx at 26) so I have an inkling of how Jeff might be feeling.

                  KatyWI

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                  KatyWI
                  Participant

                    I don't think any early results have been posted yet on the ipi stage III trial – so nobody knows if it will stop recurrence.  You could double check with the doctor who'd be running the trial.

                    I did see a new trial (which is unfortunately not yet recruiting) that compares ipi to interferon for stage III/resected.  That might be a little less "scary" than the trial with a placebo arm.  I hope this link works:

                    http://www.clinicaltrials.gov/ct2/show/NCT01274338?term=ipilimumab&recr=Open&rank=6

                    Good luck to you both – I'm 36 (first dx at 26) so I have an inkling of how Jeff might be feeling.

                    KatyWI

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                    Carmon in NM
                    Participant

                      I just completed a six month drug trial with excellent results and I'm scheduled for surgery on April 19th to remove my right adrenal gland and the tiny bit of tissue that is all that remans of a 3 cm tumor. After I recover from surgery and it is released by the FDA, my onc wants to start me on ipi as an added assault against mel.

                      She feels that since I have been such a strong responder to chemo there is a good chance I will also be one of the 25% who respond to ipi. To her way of thinking, this will be as close as she can get me to a 'cure'. UNM is both a teaching and research hospital so the oncs are willing to step out and try things a bit differently. Even though I will most likely no longer have any measurable disease after the surgery, I will be part of research to see if adding ipi will help to prevent or delay recurrance.

                      Carmon in NM – Stage 3b 9/2008, advanced to Stage 4 6/2010 with brain and adrenal mets

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                      Carmon in NM
                      Participant

                        I just completed a six month drug trial with excellent results and I'm scheduled for surgery on April 19th to remove my right adrenal gland and the tiny bit of tissue that is all that remans of a 3 cm tumor. After I recover from surgery and it is released by the FDA, my onc wants to start me on ipi as an added assault against mel.

                        She feels that since I have been such a strong responder to chemo there is a good chance I will also be one of the 25% who respond to ipi. To her way of thinking, this will be as close as she can get me to a 'cure'. UNM is both a teaching and research hospital so the oncs are willing to step out and try things a bit differently. Even though I will most likely no longer have any measurable disease after the surgery, I will be part of research to see if adding ipi will help to prevent or delay recurrance.

                        Carmon in NM – Stage 3b 9/2008, advanced to Stage 4 6/2010 with brain and adrenal mets

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