The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. Content within the patient forum is user-generated and has not been reviewed by medical professionals. Other sections of the Melanoma Research Foundation website include information that has been reviewed by medical professionals as appropriate. All medical decisions should be made in consultation with your doctor or other qualified medical professional.

Update- ipi failure? Need advice

Forums General Melanoma Community Update- ipi failure? Need advice

  • Post
    Marianne quinn
    Participant

      My husband was in the interferon vs. ipi trial for stage 3c. He had melanoma under his thumbnail with 2 nodes.  He was in the  10 mg ipi arm At week 11, he had a CAT scan whioh showed a 2 cm lesion in his liver which was confirmed by biopsy. Very distressing and he was removed from the trial as the onc said the ipi did not work since he was NED before the ipi. On May 6, he had ablation of the lesion which was smaller than the CAT scan. It was a tough surgery in that he had numerous adhesions of his liver to his diaphgram due to being hit by a drunk driver over 40 years ago! They had to remove the adhesions as well as microwave the lesions. He is recovering pretty well now, but there was a lot of pain due to the adhesions. The ablation itself was not that difficult.

      He still has side effects from the ipi of a rash and he has to watch what he eats.

      From this forum, I am sure that the ipi did not have an adequate chance to work. He will not get the maintenance doses of the trial which may or may not be a blessing in disguise. It is pretty distressing when you get tossed from a clinical trial with no further guidance. He signed 28 pages of disclosures, but it was never disclosed what the protocol should be after being removed  unwillingly from the study. Ipi has the potential of having long term, late appearing, serious side effects and I think it is immoral that the trial makes no provisions for monitoring especially when he took a dose that caused deaths.

      Hopefully, he is NED after the surgery. I think it makes him ineligible for PD1 right now. CAT scan is next week. 

      My questions are- is he really an ipi failure?  When would he be considered an ipi failure? Has anyone had good luck with ablation of liver lesions? He actually felt really good before the surgery and we were surprised that he had mets. Interestingly, he had many dysplastic nevi / age spots and they have all faded so we know that the ipi worked on something. Younger looking skin with Yervoy- a new marketing campaign for Bristol Myer Squibb.

      When I read other posts, I realize that my hubby is luckier than many people with melanoma. This forum has been a life saver for me and I am grateful for all the support and information.

      How are you doing Heidi with your trial? Please let us know.

      Is anyone at MRF to the oncologist conference this week ? I would love to know the preliminary results of the trial my husband was in.

    Viewing 5 reply threads
    • Replies
        BrianP
        Participant

          Hey Marianne,

          I'm afraid I can't really answer any of your questions.  I kinda feel like you that Ipi may not have been given enough time to work but I don't really know what clinically defines an Ipi failure. 

          I'm hoping you are NED after surgery as well which would make you ineligible for anti-pd1 at that point.  My additional hope is that your husband will stay NED for the next 20+ years so you can prove he wasn't an Ipi failure.

          Brian

          BrianP
          Participant

            Hey Marianne,

            I'm afraid I can't really answer any of your questions.  I kinda feel like you that Ipi may not have been given enough time to work but I don't really know what clinically defines an Ipi failure. 

            I'm hoping you are NED after surgery as well which would make you ineligible for anti-pd1 at that point.  My additional hope is that your husband will stay NED for the next 20+ years so you can prove he wasn't an Ipi failure.

            Brian

            BrianP
            Participant

              Hey Marianne,

              I'm afraid I can't really answer any of your questions.  I kinda feel like you that Ipi may not have been given enough time to work but I don't really know what clinically defines an Ipi failure. 

              I'm hoping you are NED after surgery as well which would make you ineligible for anti-pd1 at that point.  My additional hope is that your husband will stay NED for the next 20+ years so you can prove he wasn't an Ipi failure.

              Brian

              RJoeyB
              Participant

                I'd agree that it seems that the ipi may not have had time to work to judge whether he's truly a responder or not.  From a trial perspective, it does make some sense that he's considered to have "progressive disease".  Trials need to have an endpoint, and it sometimes seems arbitrary.  I've written about this recently, and it's hard for us patients to hear that we have progressive disease, but at the same time, the last thing I want to do is sit on my hands and wait too long, I'm ready to try what's next.  If ipi had an 80% response rate, then maybe, but at 20-30%, I don't want to wait around.  At the same time, remember that "progressive disease" doesn't mean that he failed ipi.

                I was in a TIL trial and a few months after finishing the treatment, "new" mets were found in my tibia (shin bone, below the knee).  Standard surveillance for melanoma doesn't scan below the knees unless there is symptomatic or historical reason to do it, so those bone lesions were likely there long before I received the TIL.  I was the first to notice the bone lesions after some a very mild sensation following a run at the gym.  I mentioned it when I saw my doctors for my second follow-up, which led to an x-ray and then an MRI which found two small bone mets.  My standard scan now includes a head-to-toe PET-CT instead of chest-to-pelvis CT every three months.  It didn't really impact my treatment, because I had already completed it, but hearing the news was still disheartening.  It actually meant I didn't have to keep traveling from Philadelphia to Bethesda, where I was participating in the TIL trial at NIH, for continued monitoring and instead was able to continue my treatment at my "home" hospital here in Philly.

                Sorry I can't speak to the liver met and how effective tumor ablation is on the liver.  I agree that the skin changes you speak of following the ipi can be good signs.  I've had some vitiligo, especially on my hands and feet, and significant depigmentation of many moles all over my body.  That could be due to the TIL, IL-2, or ipi — I've had all three, but regardless, my doctors love it when they see it.  Can I ask if your husband had completed his course of ipi?  The standard is a course of four doses, at weeks 0, 3, 6, and 9.  You mention his scan was at week 11.  I don't know if his trial also includes ongoing maintenance doses, perhaps with less frequency.

                 

                  Marianne quinn
                  Participant

                    He had 4 doses of 10 mg ipi. Maintenance was to start June 9. We are pretty much ok with him not getting maintenance doses as we were very concerned about the potential endocrine side effects. He has already had more ipi then if he completed the trial with the 3 mg dose. So we hope. Thanks for the support. 

                    jogo
                    Participant

                      Check the consent document your husband signed.  What does it say about removal from the study?  You could also call the Operations Office of the NCI Central Institutional Review Board (CIRB) at 888-657-3711.  The IPI may have had a positive effect.  Don't give up.  Check about removal from the study.  Treatment may have stopped, but why removal from the study?  Good luck!

                       

                      jogo
                      Participant

                        Check the consent document your husband signed.  What does it say about removal from the study?  You could also call the Operations Office of the NCI Central Institutional Review Board (CIRB) at 888-657-3711.  The IPI may have had a positive effect.  Don't give up.  Check about removal from the study.  Treatment may have stopped, but why removal from the study?  Good luck!

                         

                        jogo
                        Participant

                          Check the consent document your husband signed.  What does it say about removal from the study?  You could also call the Operations Office of the NCI Central Institutional Review Board (CIRB) at 888-657-3711.  The IPI may have had a positive effect.  Don't give up.  Check about removal from the study.  Treatment may have stopped, but why removal from the study?  Good luck!

                           

                          Marianne quinn
                          Participant

                            He had 4 doses of 10 mg ipi. Maintenance was to start June 9. We are pretty much ok with him not getting maintenance doses as we were very concerned about the potential endocrine side effects. He has already had more ipi then if he completed the trial with the 3 mg dose. So we hope. Thanks for the support. 

                            Marianne quinn
                            Participant

                              He had 4 doses of 10 mg ipi. Maintenance was to start June 9. We are pretty much ok with him not getting maintenance doses as we were very concerned about the potential endocrine side effects. He has already had more ipi then if he completed the trial with the 3 mg dose. So we hope. Thanks for the support. 

                            RJoeyB
                            Participant

                              I'd agree that it seems that the ipi may not have had time to work to judge whether he's truly a responder or not.  From a trial perspective, it does make some sense that he's considered to have "progressive disease".  Trials need to have an endpoint, and it sometimes seems arbitrary.  I've written about this recently, and it's hard for us patients to hear that we have progressive disease, but at the same time, the last thing I want to do is sit on my hands and wait too long, I'm ready to try what's next.  If ipi had an 80% response rate, then maybe, but at 20-30%, I don't want to wait around.  At the same time, remember that "progressive disease" doesn't mean that he failed ipi.

                              I was in a TIL trial and a few months after finishing the treatment, "new" mets were found in my tibia (shin bone, below the knee).  Standard surveillance for melanoma doesn't scan below the knees unless there is symptomatic or historical reason to do it, so those bone lesions were likely there long before I received the TIL.  I was the first to notice the bone lesions after some a very mild sensation following a run at the gym.  I mentioned it when I saw my doctors for my second follow-up, which led to an x-ray and then an MRI which found two small bone mets.  My standard scan now includes a head-to-toe PET-CT instead of chest-to-pelvis CT every three months.  It didn't really impact my treatment, because I had already completed it, but hearing the news was still disheartening.  It actually meant I didn't have to keep traveling from Philadelphia to Bethesda, where I was participating in the TIL trial at NIH, for continued monitoring and instead was able to continue my treatment at my "home" hospital here in Philly.

                              Sorry I can't speak to the liver met and how effective tumor ablation is on the liver.  I agree that the skin changes you speak of following the ipi can be good signs.  I've had some vitiligo, especially on my hands and feet, and significant depigmentation of many moles all over my body.  That could be due to the TIL, IL-2, or ipi — I've had all three, but regardless, my doctors love it when they see it.  Can I ask if your husband had completed his course of ipi?  The standard is a course of four doses, at weeks 0, 3, 6, and 9.  You mention his scan was at week 11.  I don't know if his trial also includes ongoing maintenance doses, perhaps with less frequency.

                               

                              RJoeyB
                              Participant

                                I'd agree that it seems that the ipi may not have had time to work to judge whether he's truly a responder or not.  From a trial perspective, it does make some sense that he's considered to have "progressive disease".  Trials need to have an endpoint, and it sometimes seems arbitrary.  I've written about this recently, and it's hard for us patients to hear that we have progressive disease, but at the same time, the last thing I want to do is sit on my hands and wait too long, I'm ready to try what's next.  If ipi had an 80% response rate, then maybe, but at 20-30%, I don't want to wait around.  At the same time, remember that "progressive disease" doesn't mean that he failed ipi.

                                I was in a TIL trial and a few months after finishing the treatment, "new" mets were found in my tibia (shin bone, below the knee).  Standard surveillance for melanoma doesn't scan below the knees unless there is symptomatic or historical reason to do it, so those bone lesions were likely there long before I received the TIL.  I was the first to notice the bone lesions after some a very mild sensation following a run at the gym.  I mentioned it when I saw my doctors for my second follow-up, which led to an x-ray and then an MRI which found two small bone mets.  My standard scan now includes a head-to-toe PET-CT instead of chest-to-pelvis CT every three months.  It didn't really impact my treatment, because I had already completed it, but hearing the news was still disheartening.  It actually meant I didn't have to keep traveling from Philadelphia to Bethesda, where I was participating in the TIL trial at NIH, for continued monitoring and instead was able to continue my treatment at my "home" hospital here in Philly.

                                Sorry I can't speak to the liver met and how effective tumor ablation is on the liver.  I agree that the skin changes you speak of following the ipi can be good signs.  I've had some vitiligo, especially on my hands and feet, and significant depigmentation of many moles all over my body.  That could be due to the TIL, IL-2, or ipi — I've had all three, but regardless, my doctors love it when they see it.  Can I ask if your husband had completed his course of ipi?  The standard is a course of four doses, at weeks 0, 3, 6, and 9.  You mention his scan was at week 11.  I don't know if his trial also includes ongoing maintenance doses, perhaps with less frequency.

                                 

                            Viewing 5 reply threads
                            • You must be logged in to reply to this topic.
                            About the MRF Patient Forum

                            The MRF Patient Forum is the oldest and largest online community of people affected by melanoma. It is designed to provide peer support and information to caregivers, patients, family and friends. There is no better place to discuss different parts of your journey with this cancer and find the friends and support resources to make that journey more bearable.

                            The information on the forum is open and accessible to everyone. To add a new topic or to post a reply, you must be a registered user. Please note that you will be able to post both topics and replies anonymously even though you are logged in. All posts must abide by MRF posting policies.

                            Popular Topics