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Ipilimumab as adjuvant therapy trial

Forums General Melanoma Community Ipilimumab as adjuvant therapy trial

  • Post
    Solodad
    Participant

    Apologies if there is already a thread on this. I tried searching for it, but couldn't find anything.

    That said, I'm interested in knowing if anyone is/has been on the clinical trial for Ipi as an adjuvant therapy. It is a randomized trial with a placebo arm, so you don't really know if you're getting the Ipi or a placebo.

    If you're in this trial,  I'm specifically interested in whether or not you can tell if you're getting the Ipi or not. 

    Thanks.

    Apologies if there is already a thread on this. I tried searching for it, but couldn't find anything.

    That said, I'm interested in knowing if anyone is/has been on the clinical trial for Ipi as an adjuvant therapy. It is a randomized trial with a placebo arm, so you don't really know if you're getting the Ipi or a placebo.

    If you're in this trial,  I'm specifically interested in whether or not you can tell if you're getting the Ipi or not. 

    Thanks.

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  • Replies
      Lori C
      Participant

      Hi,

      Will, the person I was primary caregiver for, was in this trial.  He had no side ef fects, which lead his oncologist to believe he was on the placebo arm.  His cancer advanced, and when we tried to get ipi for compassionate use (there were few other options by then) Bristol Myers Squibb refused to allow him access to it because the trial had not passed it's end point. 

      It was extremely frustrating because by then, there was data that ipi was having some good results and three melanoma specialists I took him to agreed it was the best available choice for him (only it was not available, as it turned out). 

      This is a double blind trial so other than educated guessing, there is no real way to tell if you are getting the ipi or not.  There are some blood test resultts that might point to it (I cannot recall which one, it had to do with white blood cell count, I think) and there is the presence or absence of side effects, and that's all the information you can really use.

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        Vermont_Donna
        Participant

        Hi,

          I am in a clinical trial where I KNOW I am getting IPI….I had had increased nausea (although not daily) and increased fatigue (yeah pretty much everyday I feel more tired). No rashes, no GI side effects meaning no diarrhea, no white patches of skin although under the black light I have had some pigmentation changes noted by my oncologist. After my second dose one of my leg tumors crusted over and not has pretty much gone away and a second tumor (larger than a pencil eraser) now has turned whitish in the middle, and several of my other 50 plus tumors on my leg have "changed"…feel softer to me, not so 'tumor" like. I just had my third infusion this past week. I know some here on Ipi have had no side effects…so I dont think no side effects means you arent getting ipi. Everyone is different. Good luck!

        Vermont_Donna

        stage 3a

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        Vermont_Donna
        Participant

        Hi,

          I am in a clinical trial where I KNOW I am getting IPI….I had had increased nausea (although not daily) and increased fatigue (yeah pretty much everyday I feel more tired). No rashes, no GI side effects meaning no diarrhea, no white patches of skin although under the black light I have had some pigmentation changes noted by my oncologist. After my second dose one of my leg tumors crusted over and not has pretty much gone away and a second tumor (larger than a pencil eraser) now has turned whitish in the middle, and several of my other 50 plus tumors on my leg have "changed"…feel softer to me, not so 'tumor" like. I just had my third infusion this past week. I know some here on Ipi have had no side effects…so I dont think no side effects means you arent getting ipi. Everyone is different. Good luck!

        Vermont_Donna

        stage 3a

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      Lori C
      Participant

      Hi,

      Will, the person I was primary caregiver for, was in this trial.  He had no side ef fects, which lead his oncologist to believe he was on the placebo arm.  His cancer advanced, and when we tried to get ipi for compassionate use (there were few other options by then) Bristol Myers Squibb refused to allow him access to it because the trial had not passed it's end point. 

      It was extremely frustrating because by then, there was data that ipi was having some good results and three melanoma specialists I took him to agreed it was the best available choice for him (only it was not available, as it turned out). 

      This is a double blind trial so other than educated guessing, there is no real way to tell if you are getting the ipi or not.  There are some blood test resultts that might point to it (I cannot recall which one, it had to do with white blood cell count, I think) and there is the presence or absence of side effects, and that's all the information you can really use.

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      EmilyandMike
      Participant

      I know of a couple of people who either got into the placebo or the Ipi arm and the ones in the Ipi arm did have side effects..diarreah/rash

      One thing to remember is that you must enter this trial within 12 weeks after surgery to remove lymph nodes.  And they only take 3a with metastasis > 1mm

      When Ipi is approved in March (hopefully) – it think it will only be available as a second line treatment for Stage IV

      Yet another roadblock for those with Stage 3 – it is just rediculous.

       

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      EmilyandMike
      Participant

      I know of a couple of people who either got into the placebo or the Ipi arm and the ones in the Ipi arm did have side effects..diarreah/rash

      One thing to remember is that you must enter this trial within 12 weeks after surgery to remove lymph nodes.  And they only take 3a with metastasis > 1mm

      When Ipi is approved in March (hopefully) – it think it will only be available as a second line treatment for Stage IV

      Yet another roadblock for those with Stage 3 – it is just rediculous.

       

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      Charlie S
      Participant

      Though I am sure my post will be considered jaundiced by many, it is important to understand what a clinical trial is and what it is not.

      What a clinical trial IS, is a scientific experiment that uses human beings as test subjects to explore the effacy of non-approved developmental treatments.

      What a clinical trial is NOT is  an approved adjuvant therapy.

      Stage III Clinical trials are blinded with a placebo arm for a specific scientific purpose, and as such, there are numerous roadblocks to know if you are "getting the juice" or not.

      Yes, there is anecdotal evidence from patients self comparing to reach a conclusion, but the absolute proof of actual receiving of the investigational drug/therapy is intentionally withheld.

      There is no way of actually, verifiably knowing, until and unless the trial is unblinded.

      Caveat emptor upon enrollment.

       

      Cheers.

      Charlie S

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      Charlie S
      Participant

      Though I am sure my post will be considered jaundiced by many, it is important to understand what a clinical trial is and what it is not.

      What a clinical trial IS, is a scientific experiment that uses human beings as test subjects to explore the effacy of non-approved developmental treatments.

      What a clinical trial is NOT is  an approved adjuvant therapy.

      Stage III Clinical trials are blinded with a placebo arm for a specific scientific purpose, and as such, there are numerous roadblocks to know if you are "getting the juice" or not.

      Yes, there is anecdotal evidence from patients self comparing to reach a conclusion, but the absolute proof of actual receiving of the investigational drug/therapy is intentionally withheld.

      There is no way of actually, verifiably knowing, until and unless the trial is unblinded.

      Caveat emptor upon enrollment.

       

      Cheers.

      Charlie S

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        Lori C
        Participant

        I totally agree Charlie.  Definitely "caveat emptor". 

        But going in, the patient needs to truly understand the risks.  That's why I questioned BMS's ethics in letting Will sign a 17 page consent form for a double blind placebo trial – Will had cognitive disabilities sufficient to qualify him for SSDI, and a diagnosis of Mild MR.    He could give informed consent to many things, but this was well beyond those parameters.  His brother tried to explain to him what the trial was using coins under cups….he never understood that A) he might be getting something which would do him no medical good at all and B) he would disqualify himself for  use of the drug should it prove effective in others until the trial was unblinded, date undetermined.  He was his own guardian,  but the issue of "informed consent" was really abused here.

        Lori

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        Lori C
        Participant

        I totally agree Charlie.  Definitely "caveat emptor". 

        But going in, the patient needs to truly understand the risks.  That's why I questioned BMS's ethics in letting Will sign a 17 page consent form for a double blind placebo trial – Will had cognitive disabilities sufficient to qualify him for SSDI, and a diagnosis of Mild MR.    He could give informed consent to many things, but this was well beyond those parameters.  His brother tried to explain to him what the trial was using coins under cups….he never understood that A) he might be getting something which would do him no medical good at all and B) he would disqualify himself for  use of the drug should it prove effective in others until the trial was unblinded, date undetermined.  He was his own guardian,  but the issue of "informed consent" was really abused here.

        Lori

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      Solodad
      Participant

      Well, I talked to someone at the clinic doing the study, and was told about the 12 week window. So, I don't qualify because of that. 

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      Solodad
      Participant

      Well, I talked to someone at the clinic doing the study, and was told about the 12 week window. So, I don't qualify because of that. 

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