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August 16, 2014 at 3:52 am #22137
I have been on a clinical trial (Anti-PD1 & Anti-KIR) since April 1 this year. Initially, the drug worked well and I was off to a good start. I saw a lot of tumors that resolved or even shrank. Plus, I started to feel much, much better. I have now had 2 scans during the trial and each scans showed a mixed response, but overall there was a decrease in my tumor burden. However one of my tumors, which has probably been growing slowly since January, have now grown through the treatment and is now a really large size. It’s protruding through my groin/leg and it looks like about a large pear, if I can picture it to you. The last 6 weeks, and especially the last 3 weeks, started giving me some very intense pain. I’ve been managing the pain with MS Contin, Dilaudid, and Lyrica (nerve drug). Outside of the pain and this tumor which is inhibiting my daily activities, I’d love to stay on the trial/drug (it’s an easily tolerated drug). I expressed my pains to my oncologist two weeks ago but he wanted to stay the course and reevaluate in two weeks ago. But at this point, my pain has not relieved and I don’t see this tumor shrinking anytime soon.
So at my next appt, I’m telling my doctor, if he doesn’t bring it up course, that I think it’s time to switch treatments before I start slipping too much.
I think my problem is that I’ve had a lot of treatments: interferon, mageA3 vaccine, Ipilumumab, Zelboraf, Anti-PD1 & Anti-KIR trial.
After those I’m not sure what I can do. Any thoughts what other options can be done? Should I get on chemo to try to shrink this tumor?
I know BIOchemo, IL-2, but I think I’d like to go for TIL at NIH. But I’m not sure if I’ll get in with this massive tumor in my groin.
Can anybody know if you can go for Zelboraf for a second time around? I did well on that, 13 months.
If anybody has any ideas please share your thoughts.
ShaneAugust 16, 2014 at 2:38 pm #65197AnonymousGuest
Shane, sorry to hear that. Can you still stay on the trial but have it surgically removed, or at least de-bulked with surgery, radiation or thermal (heat/cold)? Killing parts of the tumor with radiation or heat/cold (shoot, even direct injection of IL2) might have the advantage of setting off antigens which could attract the immune system. Also maybe a surgical sample of the tumor can tell you if the swelling is the tumor growing and/or the T cells invading it. If it’s T cell invasion, well that could be good news. My point being, you might just have some options available for that specific tumor but still stay on the trial so, of course, have a serious discussion with the Doc concerning some creative options. He/she, of course, would have to check with the trial sponser.
Also, you might be able to jump to one of the PD1 expanded access trials and they may let you remove/treat the large tumor before starting the trial.
Just some thoughts.
JeffAugust 16, 2014 at 3:58 pm #65198RJoeyBParticipant
I wouldn’t think the groin tumor would disqualify you from TIL, has someone told you that it would? With TIL, at least at NIH, you actually need two different tumors/lesions to participate. One needs to be resectable, from which the TIL cells will be harvested and grown, and you then need another one (or more) that are “measurable disease” that are used to monitor response using RECIST criteria. So perhaps the groin lesion could be used for the TIL harvest.
I had TIL in 2010-11 at NIH. My primary lesion on my back was originally planned to be used for the TIL harvest, but after it was resected, the cells grew too slowly, so I was switched to the high-dose IL-2 arm of the trial. Eventually, the cells started to grow, but by that time I had a new met in my small intestine that needed to come out before proceeding because they were concerned about a bowel perforation during the IL-2 or chemotherapy parts of the TIL protocol. So I had a partial small bowel resection to remove the tumor and they also tried to harvest TIL cells from it. They grew very quickly and they ended up using those cells for my TIL cell infusion. The other note about “measurable disease” is important because some mets, even of a fair size, may not be considered “measurable” for RECIST purposes. I had two other mets, one in my proximal humerus (upper arm bone) and one in a node in my underarm. The bone lesion, while a few centimeters in size, couldn’t be measured with sufficient accuracy to be used as the measurable site, but the axillary node was, so I was eligible for the trial.
I hope that information helps,
JoeAugust 16, 2014 at 4:41 pm #65199
I, too, am sorry to hear about this issue and the pain you are experiencing. I thought of surgery first myself. Are you on the BMS PD1 or Merck? If the BMS, then you could go into the EAP program for the Merck PD1, but not vice versa. Have you thought of trying the Glaxo combo of braf/mek, (taflinar/mekinist) it was proven to work better than the BRAF drug alone. Since it has been a while, I imagine that you might have a good response. I would be good to either radiate or surgically remove the tumor to stop the pain if possible. Pain just wears us down as you know.
I’m not a proponent of the TIL program until I see more evidence of it working for a large number of individuals. So far, just a small sample and I’ve worked with many who recurred after TIL.
So I hope you find this helpful and wish you the best on this..be sure to keep in touch with us.August 16, 2014 at 5:10 pm #65200
Hi guys, thanks for your quick responses.
Jeff, I definitely mirror your thoughts by surgically removing the groin tumor, and then staying on the trial. To me, this is the ideal option if possible. The problem I’ve been getting from the oncologist, plus a surgeon that I saw a month ago for a mandatory biopsy for the trial, and I got another opinion from MDA over the phone after reading my recent scans, that this tumor can’t be surgically removed. This leaves me almost no option of staying on the trial. As far as radiation I will bring that up to my doc, but I never heard about injecting IL2 directly into tumors. Has anybody ever have experience with that? I don’t think I’ve ever even came across this in any literature. Interesting though if it can be done.
Regarding to the TIL, which I think is my next choice of treatment if needed, I have not been told that this tumor would disqualify me from trying for the TIL trial, I’m just wondering if this could prevent me from going for it. I still have many accessible subdermal tumors that can used for TIL. I know that to enroll into TIL you have to be strong enough to tolerate the treatment. And in my opinion, without doing something about this groin tumor, I will get worse. The location, the pain, and limiting physical movement is frustrating.
Although I still have many small tumors, it just seems that this one problematic tumor is causing most of my troubles.
Thanks again for your input,
ShaneAugust 16, 2014 at 5:34 pm #65201
I did try the Glaxo combo of braf/mek, (taflinar/mekinist) for a few weeks back in February. However I switched onto that after being on Zelboraf for the previous 13 months when the drug was starting to fail. In my case, at that point, I started progressing fast and I don’t think the taflinar/mekinist had a chance to work. Although I technically deemed fail – I’m jot sure.
Currently I am on BMS Nivolumab so it sounds like that I could switch over to the Anti-PD1 EAP by Merck. The problem is finding a solution to the tumor in my groin that is causing so many problems and intense pain. If radiation was an option is this relatively straight forward? Can this done at most cancer centers? Or should I be looking for another specialized radiation center? I’m currently at Univ of Chicago.
One other question regarding switching to the Merck Anti-PD1 drug; is there any option to get the higher dosage? I remember reading during the trials that there was different cohorts with different dosages. Is there any way to seek out for higher dosages? Since I have a higher burden of disease, I’d prefer chancing for the higher dosages. Is this even possible? Or have they already settled on the dosage?
ShaneAugust 16, 2014 at 7:19 pm #65202
I don’t know about dosage and would guess that is up to the principle investigator at the site.
For radiation, I would definitely go to a very top notch center (which U of Chicago should be) for pinpointed radiation. Have you had a surgical consultation?
And finally, it might be worth trying the taf/mek combo since you’ve been off it a while. Maybe it would work for some quick tumor regression? I hope your doctor is working closely with you to help with these decisions.August 18, 2014 at 11:28 pm #65203MariaSParticipant
If you decide to go the TILs route, the tumour that bothers you can be resected and used to grow the TILs. The link below is the story of an amazing lady that had a huge tumour in the groin and did the TILs procedure. She was very honest throughout the treatment, she wrote about the good, the bad, and the ugly of it. At no point did she say this is the right way to go, just shared her experience.August 19, 2014 at 4:39 pm #65204kylezParticipant Hi Shane,
Sorry you’re dealing with a tough stubborn situation on that tumor. Mixed responses make me think of ‘tumor heterogeneity’. Which if it’s true, can attacking from very different angles help? From what you describe I would definitely be thinking about next steps too.
Catherine, what is the thinking if any about heterogeneity? In my case my past/present 3 treatments have been immunotherapies up to and including this PD1/KIR trial. I wonder if my current tumor has the same mutations as the ones from 2010-2011 did. For me I wonder if AKT + MEK would be a good try at a different angle. Although I would probably try IpI again first.
But I don’t know how real ‘tumor heterogeneity’ is. I. wonder if any place is sequencing every tumor. Or maybe there are factors other than mutations between tumors. I don’t know what oncologists are saying about such things. Mine did say my current recurrence is probably from a small colony of mutant cells. But mutant vs. what? My past tumors? I’ll ask him next time.August 19, 2014 at 6:52 pm #65205
Here is my take on how cancer works/or melanoma. Melanoma is known to misbehave not always showing up where it is supposed to etc. When the melanoma cells are shed from a tumor, they colonize and work on setting up another tumor with blood vessels etc. to feed it. They fool the body into thinking it is another organ to take care of. There are mutations within these tumors and I’d say we’re still figuring it all out. But I agree, attack at all angles, try to outsmart the tumor cells with new strategies. This is the best way I understand it and can explain it.August 20, 2014 at 6:37 am #65206lak1Participant Has anyone tried injecting rose bengal into such misbehaving tumours? I know there was a presentation ?poster at ASCO and a trial in the US for this. It reportedly kills melanoma cells and can induce an immune response – surely what is needed post ipi or pd1August 20, 2014 at 11:23 am #65207 I think this therapy has been struggling for approval for a few years now. I haven’t seen any convincing evidence of it having high response rates.August 21, 2014 at 11:11 pm #65208 Hi, just wanted to update where I’m at after this weeks appointment with my oncologist and surgical oncologist. I also had an updated CT scan which helped. I started off with my oncologist and he gave me some possible options to treat this groin/pelvis tumor. Many of which we discussed in this thread. Ideally, surgically removing the tumor was everyone’s first choice. However, after meeting with my surgical oncologist (who I really like and trust him – have known him for almost 14 years and he operated on me a few times already), said that this tumor is too fixed and attached to deep into the pelvis to operate on. It was too dangerous and risky to go into nerves and blood vessels, etc. So this was bad news.
Both doctors then read my latest CT scan and it showed a similar story from other scans; mixed response, and relatively stable except the groin/pelvis tumor has grown again. I was able to reach out to a few other doctors (who are familiar with my case), and basically said I needed to pull out of the trial and new a different treatment. It’s unfortunate as I mentioned I kinda like the Anti-PD1 because no side effects for me, and it has helped me over the last almost 5 months.
I ended up deciding to try and go for the NIH’s TIL program. I was able to get an appt to see their team in Bethesda this coming Tuesday. Hopefully now I can pass the brain scan and their physical. I know this treatment is pretty intense and can be toxic, I just feel that it’s the time for me to chance it.
Thanks for all the replies and responses – if anybody has any other thoughts please let me know.
-ShaneAugust 22, 2014 at 12:10 am #65209BNP68Participant
Best of luck with the screening process Shane. I personally think that’s a great option and would probably do the same if in your shoes.
BrianAugust 22, 2014 at 1:31 am #65210RJoeyBParticipant
I’m glad you were able to get an appointment at NIH relatively quickly — not sure from where you’re traveling, but I wish you safe travels (if you do end up enrolling in one of their trials, they’ll cover your travel expenses to/from Bethesda). A couple of things for you as you further consider TIL:
1) They have several TIL trials running, so make sure you understand which ones you’ll be considered for and are options for you. I know one of the trials is looking at adding total body irradiation (TBI) to the standard chemotherapy as part of the non-myeloablative preparatory regimen prior to receiving your cells (this is the part where they wipe out your existing circulating white blood cells, but not the bone marrow itself). There are three arms, two with two different doses of radiation, and a third that doesn’t use radiation. I believe there is another variant that reduces the preparatory chemotherapy regimen from what they’ve been using for awhile now — the “standard” is two days of cyclophosphamide and then five days of fludarabine, I think the one trial is comparing it to one day and three days, respectively. And finally, I believe there is a trial variant that compares the elimination of the round of IL-2 after the TIL infusion (for most people, the IL-2 is the roughest part of TIL, it was for me — the chemotherapy wasn’t as bad as I expected, the TIL infusion itself is a 20 minute IV with no side effects, but the IL-2 can be rough). There may be other trials, but those are the ones I’m aware of and I’ve tried to stay on top of what else is available (I’ve been told TIL retreatment is a possible option and would consider it if needed in the future). So try to come away with an understanding of which trial(s) you are being considered for and feel free to post back here when you know more — I’d be happy to explain more if you have questions (now or after your appointment).
2) Keep in mind that with any of the trial variants, there will be a waiting period after the “harvest surgery” (where they remove the tumor from which the TIL cells will be removed and then grown) and when you actually receive the TIL cells back, while they are grown in the lab. They usually say 4-6 weeks. I had complications with my first harvest (long story), but ultimately the cells they grew from a separate tumor resection grew quickly, in about three weeks, then there was that week inpatient for the chemotherapy preparatory regimen, so in total, it was about 4-5 weeks from the day of my surgery to the day I got my cells. I mention this to you because I know you are struggling with pain in the tumor in your groin right now. You might want to consider getting their opinion on having radiation on that particular tumor while you are waiting for the cells to grow (and also recognizing that there is the possibility that the cells won’t grow), even if the radiation is done with a more palliative intent to manage the pain. They likely wouldn’t do the radiation there (at NIH) but could coordinate/consult with your home hospital if it’s an option.
Wishing you the best for your visit to Bethesda. I was in a much different place in my own journey when I was there; it was right after I was diagnosed and was the first treatment I went through, so everything was pretty overwhelming. But all of the doctors, nurses, and staff we met, from the intake visit days through to the trial were all terrific. In the meantime, again, glad to answer any questions you have ahead of your trip.
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