Home Forums Melanoma Diagnosis: Stage IV Zelboraf / IL-2 trial advice

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  • #21698
    Bradcope1
    Participant

    My daughter is stage 4 and currently is enrolled in the phase 4 Zelboraf / IL-2 trial. Last week we were excited to receive confirmation that the single tumor in her lung is shrinking on the Zelboraf arm. After six months of coughing, Z stopped it in 2-3 weeks. We need the collective wisdom of this community now as we are getting cold feet about the IL-2 arm which is scheduled for the week before and the week after Christmas. On this site, I have heard IL-2 referred to as a last resort. I have also seen the 6% of full responders believing in it and the 94% that didn’t respond calling the experience a nightmare. Her oncologist says it is the first resort, because of your age and good health. On paper the trial makes sense, as we know that the Zelboraf response is not durable and a combo approach is needed to keep it down. It is our understanding that surgery is an option for her, but her Oncs sold us on going the systemic route from the beginning. Not sure if another reputable melanoma clinic would necessarily agree. Any thoughts on this trial, or other directions with the newer drugs we should consider for the combo treatment?

    Thanks in advance.

    #63119
    Anonymous
    Guest

    Boy, that’s a tough one. Being a phase IV trial, is there any existing response data available to help guide you?

    Surgery would be attractive too but that is invasive, may require a lobe removal and is not systemic.

    Systemic HD IL-2 is very rough on the patient, but she is young and recovery from the SA’s is usually quick and there is that ~6% cure rate and 15-20% response rate. But it is very rough.

    I read of some earlier studies where IL-2 was injected/applied directly into the tumor. This local therapy was effective against that specific tumor :

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2335290/

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=719043&version=HealthProfessional

    That might be preferable to surgery. Just a thought and may be worth checking out with your Onc and/or a call to the NCI.

    There are also the new PDL trials openning up.

    Have you gotten second opinions?

    Jeff

    #63120
    lizliz
    Participant

    For what it might be worth, I had a single lung met in 2009. I had the upper left lobe of my lung removed in March 2009 and with no other treatment, I remain NED today. I have gained back 80% of my lung capacity and I have completed two half marathons sice recovering and feel very blessed. For me, surgery was sucessful.

    #63121
    ncdaniel
    Participant

    IL-2 can be rough but I can tell you from my wife’s experience (61 years Old) she had two weeks of it 11 doses with almost no side effect. The only draw back was in her case she only had a slight response. The other thing is many trials and other options do require IL-2 treatment before other options are available. Good luck and keep fighting.

    #63122
    Bradcope1
    Participant

    Thanks everyone, you were a big help. Liz, had you done any previous immunotherapy of any kind before doing surgery?

    #63123
    lizliz
    Participant

    I was informed about the interferon and was told by my Dr. that he would not recommend the harsh treatment in my case. I am glad I followed the advice, because I feel that my immune system is strong. I think that is why I am in remission almost for 5 years after a stage IV diagnosis.

    #63124
    Catherine Poole
    Keymaster

    I looked the trial up, NCT01683188, it is phase 4 only because they are using two approved therapies, Zelboraf and IL2. But nothing is known about how these two may interact. Both have toxicities associated with them, IL2 in particular requires a stay in intensive care. I haven’t seen it at any of the highly recommended melanoma centers. I would be cautious with this mix.

    #63125
    PatW
    Participant

    The BMS Nivolumab (anti-PD1) + Ipilimumab (anti-CTLA4) Phase 3 trial is called “Checkmate 067” ( NCT01844505). It sounds like a great trial not only because the Phase 1 results were so good, but because there is no placebo group– you either get Yervoy or anti-PD1 or both.

    What puzzles me, however, is that when I read the ClinicalTrials.gov write-up, it says that the inclusion criteria require “Treatment naïve patients”. Then, in the next paragraph, the exclusion criteria include: “Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody”.

    So which is it? To get on this trial, do you have to be completely treatment naive? To me that means NO prior treatment– no radiation, no Zelboraf, no interferon– nothing. Or do you just have to be naive for anti-CTLA4 and anti-PD1?

    (Note that a new termininology is starting to be introduced in the field. It appears that melanoma specialists are reserving the term “immunotherapy” to mean IL-2 and interferon. These new immune-based therapies (anti-CTLA4, anti-PD1, anti-PDL1, etc) are being called “checkpoint inhibitors”– hence the name of this clinical trial. I helps to keep up with the jargon.)

    #63126
    Bradcope1
    Participant

    Pat, do you know how the levels of toxicity of this combo trial compare to IL 2 therapy? I’ve heard that it is much more toxic that most of the modern therapies, but my guess it is not very close to IL2 alone or potentially IL 2 and Zelboraf. Perhaps this is not measurable. The responses to this trial are indeed impressive!!

    It would be nice to have it as an option. Where are these trials?

    #63127
    PatW
    Participant

    Brad, I just sent you an email. You can view the trial locations at the clinicaltrials.gov web site http://clinicaltrials.gov/ct2/show/study/NCT01844505?show_locs=Y#locn” class=”bbcode_url”>http://clinicaltrials.gov/ct2/show/study/NCT01844505?show_locs=Y#locn

    #63128
    Bradcope1
    Participant

    I believe Catherine confirmed after seeing the fine print that we are not eligible because of the Zelboraf, but will talk to Sloan and others if possible to get their take on it. Also want to explore the surgical option with them as well. Thanks Pat

    #63129
    Catherine Poole
    Keymaster

    Yes, the confusion is in the Inclusions it says treatment naïve, and exclusions just says PD1. Not clear at all, but verified with the docs/BMS it is treatment naïve. This is not a toxic trial at all, very promising.

    #63130
    PatW
    Participant

    Thank you so much for looking into this for us, Catherine.

    This is going to be a VERY highly sought-after trial, so I want to be sure I’ve got the facts straight…

    For the BMS Checkmate 067 (ipi or anti-PD1 or both) you have to be Stage IV or Stage III unresectable and have had NO prior treatments– no ipi, no Zelboraf, no interferon–nothing. I assume surgery or radiation is OK, but nothing systemic. Is that correct?

    I have no idea where they are going to find 916 patients who are completely treatment naive, but it’s their ball so I guess we play by their rules.

    #63131
    Celeste Morris
    Participant

    This whole thread has kinda been side swiped by posts regarding the ipi/nivo combo…. But, since that is the case, for those of you interested: I posted a synopsis of “Safety and clinical activity of nivolumab in combination with ipi in patients with advanced melanoma” by Wolchok, Sznol, et al as written for ASCO, on my blog June 1, 2013. There is a graph included with a breakdown of the results. At the bottom of a post on June 11, 2013, in “Random Gleanings” I note the concerns that have been relayed to me by folks at Moffitt on more than one occasion. While very promising, the side effects of this combo can be worrisome. Not as toxic as IL2, nor the life sentence that is melanoma untreated, but I think we have to be realistic about what the experts are saying and the data demonstrates. I wish all ratties embarking on this venture every success. Celeste

    #63132
    NYKaren
    Participant

    Hi everyone. Everything status quo with me…starting Tafinlar/Mekinist (sp) (adding Men to the Taf)

    I just want to add one thing…when I did IL-2 at Yale New Haven, they have a beautful unit dedicated to that treatment, not ICU. They do check on you all the time, but just so ya know.

    The docs there are top-notch. And just like everyone says, it’s a very tough regimin to go through, but you start feeling better just about as soon as your IV is removed.

    Everyone’s different. Many say that Ipi is easy, for me I had Colitis and needed Remicade (2 doses) to get over it. Also developed adrenal insufficiency. As they say in the old country, Oy Vey!

    Happy Holidays to all, and Here’s to Beating the Beast in 2014!

    Karen

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