Home Forums Melanoma: Stage III Stage IIIC Diagnosis and clinical trials

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  • #21536
    lindamg
    Participant

    My husband was diagnosed this summer with Stage IIIC melanoma.

    The initial melanoma (he called his doctor the first day he spotted it) was a .91mm mole on the left side of his torso diagnosed as melanoma in January 2012 followed at that time by a SLN biopsy (took out 5) in his left axial lymph nodes and a wide excision at the original site. All of this tissue tested negative for melanoma and he was stage Ib,based on the fact there were 3 mitosis/sq. mm

    During his recurring 3 month checkup this June 2013 his doctor found an enlarged node. Two nodes were subsequently removed and tested positive for melanoma. A PET/CT scan indicated everywhere else was clear. A total lymph node dissection (left axial) followed on June 27. Five more nodes were found with microscopic disease, for a total of 7 melanoma positive lymph nodes. Given the number of involved nodes and the fact that one was extra capsulated, followup radiation to the local area was recommended here where we live (and we got a second opinion at MD Anderson), and he had his last radiation treatment on August 20.

    We have started the process to enter the IPI clinical trial, which has interferon as one of the three arms, but have to wait the required time post radiation treatment and have scans redone which hopefully show he is still stage III. We are still looking for other clinical trials as well, since we are concerned he may get the interferon arm.

    Two other trials are the GVAX trial at John Hopkins (Sidney Kimmel Cancer Center) and the MAGE-A3 trial at the University of Virginia, although we don’t know yet if his lymph node tumors expressed the MAGE-3 protein. Does anyone here know anything about these trials, or are perhaps in either of them?

    Thank you for any advice! I’ve been reading on this site and am very impressed with the help and support.

    Linda

    #62279
    Catherine Poole
    Keymaster

    Linda,

    You are finding what most stage III folks run into, little choice. Interferon may delay recurrence but doesn’t affect overall survival. IPI/Yervoy has a 15-30% response rate and is much less toxic, so that would be the optimal choice if you had one. We do have a patient here on the Mage A3 trial and she is doing well, I believe it is Linny, you might research her posts. The vaccines have never had a good record for melanoma, but this one may be worth looking into if he tests positive. You are on the right track, looking for stage III trials and I will do some research and see if there’s anything new out there. Hang in there!

    #62280
    Linny
    Participant

    Hi Linda,

    I’m the one participating in the MAGE trial at Johns Hopkins. Unfortunately the trial I’m in is no longer accepting participants. It’s a 5 year trial and I’ve just reached the 2.5 year milestone. :mrgreen: The injection phase is finished and now I’m under observation with scans every 6 months.

    The study I’m in is a double-blind study in that neither my doctor nor I know if I’m getting the vaccine or the placebo. My post injection side-effects do appear to consistent with the reported side-effects. They were mild and included fatigue, nausea, and a general feeling of malaise that usually went away after about 24-36 hours.

    If you do opt for the University of VA study, your husband will have to undergo some testing to see if he qualifies. First and foremost, his tumor will have to express the MAGE protein. Then he’ll probably have to have a CAT scan and MRI to rule out any additional disease.

    When I last asked my doctor about what he’d heard about how the trial was going, he had told me that all the participants were doing well, even those on the placebo. Vaccines don’t seem to have a good track record, but like Catherine pointed out the MAGE vaccine has potential and so far I haven’t read anything negative on it.

    I don’t know much about the melanoma GVAX trial at Hopkins but my surgeon, Dr. Jacobs, and my oncologist Dr. Scharfmann are wonderful. Hopkins is huge and at first its size intimidated me, but I’ve no complaints whatsoever about the care I’ve received there.

    #62281
    lindamg
    Participant

    Catherine and Linny,

    Thank you both for your quick replies.

    We agree that the IPI trial is the best option, I just wish it didn’t have an interferon leg. I understand that there has to be a comparison for a fair evaluation, but it seems like there is so much data on Interferon already. We are hoping that he gets in one of the two IPI arms.

    It’s informative to hear your opinion is more positive on MAGE-3 than GVAX option.

    Linny – how was your tissue tested for MAGE-3? All that is available for my husband are tissue slides from earlier pathology work following his dissection. I don’t know if that provides what they need.

    Congratulations on finishing the trail and I certainly hope the treatment continues to work for you.

    Linda

    #62282
    katie1
    Participant

    Hi Linda,

    My husband (IIIC) has just completed the induction phase of the Ipilimumab (he was randomized into the 3mg/kg arm) vs. Interferon trial. Side effects have all been manageable (puritis, rash, and blepharitis have required topical steroids/antihistamines) and he has been able to continue his usual schedule. He too was not enthusiastic about the option of Interferon. In this trial, you have a 2/3 chance of receiving the study drug. There isn’t much data available yet as to the efficacy of Ipilimumab in high risk melanomas (pilot study was very positive, results of larger studies (EORTC 18071) won’t have any results until 2014….statistics quoted above are for metastatic disease (I think the hope is that it will be more effective with minimal tumor load)

    There is another adjuvant trial http://clinicaltrials.gov/show/NCT01667419 of Vermurafenib vs Placebo. To qualify for this trial you must be BRAF positive (my husband is negative). This is a double blind trial vs a placebo. At our center, none have been enrolled (apparently most of the people have been BRAF negative) plus it has been taking a long time to get the mutation results back from the company associated with this trial (and in at least one case the start deadline passed before the results were obtained).

    Good Luck,

    Katie

    #62283
    Linny
    Participant

    lindamg wrote:

    Linny – how was your tissue tested for MAGE-3? All that is available for my husband are tissue slides from earlier pathology work following his dissection. I don’t know if that provides what they need.

    Congratulations on finishing the trail and I certainly hope the treatment continues to work for you.

    Linda

    Actually, I’m not done yet with the trial. ;) Just finished with the injection phase. The trial won’t end until 2016. I’m in the observation phase of it now.

    They actually used tissue from the original lymph node that was removed to see if it was MAGE positive. But I remember that we had to act quickly to meet the criteria because it was time-sensitive. I had to start the trial within a certain number of weeks from my lymphadenectomy. But the one you’re looking at may be different

    #62284
    lindamg
    Participant

    Katie,

    Thank you for the information on how your husband is doing with ipilimumab in the clinical trial. I hope this works for him.

    We have looked at the vemurafenib trial, and it would only be a couple of hours away, but my husband felt with the placebo leg, it would not be the best choice. I think maybe a 50% change at it is not that bad odds. However, we are still waiting on the BRAF testing and the 90 day (I think?) deadline is not that far off. His oncologist is against any trial with a placebo leg, but he also is telling us that interferon is more effective vs. what I read about it. It is difficult to weigh these decisions.

    Your note makes me hopeful about the ipi trial. Thanks.

    Linda

    #62285
    lindamg
    Participant

    Linny,

    Thank you for the info on tissue testing. I had emailed the contact at the University of Virginia about the MAGE-3 clinical trial that I mentioned in my first post. She was very prompt in getting back to me, but unfortunately stated that trial has closed. I would really like to find another MAGE-3 trial, but no luck yet.

    She did suggest another trial http://clinicaltrials.gov/ct2/show/NCT01585350?term=Mel58&rank=1” class=”bbcode_url”>http://clinicaltrials.gov/ct2/show/NCT01585350?term=Mel58&rank=1 A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients (MEL58).

    Linda

    #62286
    Catherine Poole
    Keymaster

    Linda, you might want to read this article or pass it onto your doctor: http://theoncologist.alphamedpress.org/content/10/9/739.full

    You can always leave a trial if you get the placebo or the interferon. Soon we will have something better approved!

    #62287
    lindamg
    Participant

    Catherine,

    Thank you for the link to the article. We have showed some of that data to the doctor, who originally told us that interferon helps 30% of patients with Stage IIIc melanoma (???) I left that meeting quite upset since I had been reading everything I could find about interferon.

    I will send him this link. In my husband’s last exchange by email the doctor had backed off a bit saying that yes most of the improvement had been thought to be in the earlier stages, but there was some new data saying that it helped everyone some, even stage IV. I will say that he seems to be a nice person, but is a broad oncologist and covers several cancers. The surgery and radiation oncologists have been wonderful. With the online resources and sites like this one we feel we can find out what we need to about stage III options, but will go to a specialist if Stage IV happens.

    I hadn’t thought about leaving a trial with placebo, but maybe it is possible to tell? That is worth considering.

    Thanks.

    Linda

    #62288
    katie1
    Participant

    Linda,

    For the Ipi vs Interferon trial your husband will know exactly what drug he is randomized to receive. This is NOT true with the Vemurafenib trial. It is a double blind study (and therefore you will not know for sure what drug you receive) perhaps this information will be part of the evaluation of your trial choices.

    You always have the right (at any time) to withdrawal consent for the trial.

    Katie

    #62289
    Catherine Poole
    Keymaster

    You will know if you have vemura (Zelboraf) because the side effects are pretty pronounced. I imagine the placebo is saline or glucose? Not any standard of care which they have to offer in stage IV trials, which unfortunately is old chemo that has little response.

    #62290
    Linny
    Participant

    What you get with a trial that has a placebo is close observation, which is not a bad thing. The close observation will consist of regular scans and doctor visits. The interval at which they will occur will probably depend upon the study. The doctors will be right on top of whatever is going on inside your body.

    #62291
    lindamg
    Participant

    Linny,

    Thank you. That is something we had not considered.

    Linda

    #62292
    Catherine Poole
    Keymaster

    The majority of trials tell you upfront what agent you are receiving, the dosage may be blinded. But for example the IPI/interferon trial, you will be told which agent you are receiving. Yes, a general oncologist is not going to be up to speed normally about melanoma. You truly need a specialist because so much has happened in the research world. I believe the zelboraf trial for stage three may be blinded to a placebo. I will research that.

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