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November 27, 2013 at 5:00 am #21687
I’ve been posting in the Stage III section but now my husband Steve has progressed to Stage IV.
Brief history is .91mm mole noticed about two years ago just before Christmas and removed in early January, positive for melanoma, with clear margins and sentinel lymph nodes. In late spring this year it was in his lymph nodes, detected through the 3-months checkups, and he was Stage IIIC. He got in the ipi trial for Stage III and just prior to the 4th infusion one new skin lesion appeared same torso side as the original and a few more under the skin bumps appeared. Two were removed and biopsied and both positive. PET scan showed several more areas positive for melanoma in his lungs and vertebrae. He did get the 4th ipi infusion, and we are hoping for some delayed results from that. Steve is Braf negative, but we are going to ask for a retesting.
We are looking for a PD-1 trial. Like everyone else we’d like one where there is no chemo arm or ipi arm (would be disqualified anyway) and I don’t know if that is possible. Tomorrow I’m checking with MDA as they appear to have one available per their website, but I’ve learned that sometimes trials are closed anyway. There is a Nivolumab trial in St. Louis, not too far away, with one chemo arm. That would be better than nothing.
I saw Rochelle’s post about a PDL trial. I haven’t seen anything about PDL results, so if anyone has any additional information that would be great.
Are there suggestions for any other treatments post ipi in Stage IV besides PD-1, IL-2, or TIL?
LindaNovember 27, 2013 at 9:51 am #63054MathewRParticipant
Linda, take a look at this Merck PD-1 trial: NCT01295827. It appears to have arms/cohorts that do not require you to be ipi naive. Please let us know what you learn. I haven’t called any sites to confirm.November 27, 2013 at 12:42 pm #63055 I’m checking out this trial. I think I was told many locations were closed, but I will check again. Merck has closed all refractory Pd1 trials that I know of. (meaning if you progressed on IPI) and only has a few IPI naive open. BMS has some slots open for PD1 (IPI refractory) but these are randomized to chemo without cross over. This may be your best bet at getting PD1 now. The ADC trial is a possibility and only at a few locations though. There is also a Zelboraf/PDL and some PDL trials. We don’t know a lot about PDL but it works similarly to PD1. I believe only Genentech has the PDL in trials. I will try to get some answers when folks open up..
The best course of action is to call the site and ask to speak to the trial coordinator and get the scoop directly. Sometimes an opening pops up and certainly it is very hard to keep the clinicaltrials.gov site up to date. The horses mouth is best.November 27, 2013 at 8:11 pm #63056
We are checking at MDA for that trial. We went to MDA in July for a second opinion with the Stage III diagnosis and so are in their system. After an email from Steve to them late yesterday, our contact from Dr. Wen-Jen Hwo’s office called us back and we have an appt. for Dec. 12. She couldn’t say anything specifically about NCT01295827 (Merck PD-1) but said that the drug companies are getting ready to reorganize some trials and some seats should be available for PD-1 and this was happening around this holiday season time. So, nothing very definitive but if we learn anything there I will pass it along. I appreciated the quick response time on the day before Thanksgiving and the quick appointment.
Catherine, I’ll check into the ADC trial. Maybe that would be a backup or the second alternative down the road.
LindaNovember 30, 2013 at 2:30 am #63057AnonymousGuest
I’m sorry to hear this for Matt and you. Yes, by all means check out the ADC trial but they have an 8-12 week post IPI waiting period.
Also have your doctor immediately call the NIH concerning TIL. It’s rather grueling (but so is IL-2 by itself) but when it works, it’s very effective. If your husband is young and in good physical condition, he may be a good candidate.
Concerning IL-2, its response rate by itself is low (~15% but with a well documented 5-6% complete response rate). There is also some suggestion I’ve seen that it works better when given about 4-6 weeks after IPI but I’ve seen no studies or trials concerning it.
Finally, get radiation for the mets on his vertebrae. This is a palliative treatment (pain avoidance) and insurance should cover it.
JeffDecember 1, 2013 at 8:00 am #63058
Thank you for your comments. What are your thoughts on NIH vs. MDA for TIL? I know NIH has more trials.
Steve is 67 but in good health. I have noticed that some of the TIL trials at NIH have an upper age limit. I had wondered about radiation for some of the mets. So far there is no pain at all and he still feels fine — but I know this is likely to change. We will ask about this.
LindaDecember 1, 2013 at 1:28 pm #63059
NCI Til therapy is very selective in who they take, must be young and fit. They also have results the other two centers (MDA and Moffitt) can’t match. There has been no real definitive measurements of outcome with TIL, so I disagree with Jeff about how promising they are. While the other current therapies in trial go through 3 phases to truly prove their ability to provide a response, there has not been a comparative trial with TIL. It is extremely toxic therapy that takes the body to having no immune system and then attempts to bring it back.
PD1 has the best proven response rate of 41% but trials by Merck for ipi refractory are closed. The PDL by Medimune/Genentech is currently recruiting and quite promising and allows prior IPI. Please see the post on that here by Martha Rochelle. BMS is recruiting for IPI refractory, but there is no crossover should you be randomized to the chemo and progress. I would not travel to MDA unless they have definite slots open for PD1 or PDL since you may have to travel elsewhere to get what you’d prefer. I personally think the new therapies are the best way to go and not the old that we clearly know the results. Don’t forget that we provide travel scholarships to trials too!December 2, 2013 at 4:10 pm #63060
Thank you. We will go to MDA anyway since we lived in Houston for a long time, have lots of friends there, and know some doctors who work at MDA. There is no melanoma specialist where we live, although the doctors have been great, we really want a specialist consultation. I know we will still probably have to travel elsewhere for a trial, but are fortunately able to do that.
Has there been some news that PDL is not quite as promising as PD-1? But I will definitely still check that out.
With TIL, that does concern me to take down the immune system, but if PD-1 doesn’t work out, (and possibly PDL or ADC) then with Steve being Braf negative, there just isn’t much to try. Should he try IL-2? What is the correct sequence of drugs/trials to try? Those are tough questions and not easily answered. It is so hard to just give up. Steve seems to have a very rapidly progressing case.
I really appreciate all the comments here.
LindaDecember 2, 2013 at 4:38 pm #63061
I’ve been looking for the clincial trial for the PDL drug. I looked at the Sloan-Kettering site and only saw a trial that precludes anyone taking ipi. If you have any more information, would you let me know?
LindaDecember 2, 2013 at 6:36 pm #63062
The PDL trial, listed here: http://clinicaltrials.gov/show/NCT01693562does NOT exclude prior IPI patients. I would look at the locations listed and contact the investigators at your chosen location. IL2 is very toxic and usually reserved for last ditch effort and has a known 6% response rate. For now, I would go with the immuno therapies or the ADC for the least amount of side effects but more optimal results. Let us know how things go.December 3, 2013 at 10:47 pm #63063 Thanks.
I’m checking out that trial. I’ve contacted (left messages) Nashville twice asking about trials, specifically ADC, but haven’t heard back yet.
If there is no immunotherapy and ACD is not available, does anyone have an opinion on whether a round of a chemo drug is worth it to try to buy time to wait for a PD-1 trial?
LindaDecember 4, 2013 at 12:27 am #63064rochelleParticipant
Is it possible Steve could get another round of Yervoy? Not sure from your posts but it sounds like he has only had one course. Some chemos may exclude him from future Pd1 trials that are trialing Pd1 v chemo. I was excluded from a Merck trial because I was previously treated with two out of the four protocol chemos.
MarthaDecember 4, 2013 at 2:26 am #63065
That is a good point. Thanks. Steve had four rounds of ipi three weeks apart, and if he had another infusion, it would be in three months. We could ask about another one in a three week interval.
LindaJanuary 15, 2014 at 5:02 pm #63066
Steve got his first infusion of the ADC drug at Sarah Cannon yesterday. This is the expanded phase 1 this trial.
We were able to see Dr. Infante before Christmas, but found there were no openings in the trial at that time, but he thought one would open up soon which it did. Tumors have grown larger in his lungs and other locations in the last few weeks so hopefully this will do something positive for him. We also think some of the sub-surface nodules have shrunk some, so are hoping that perhaps a delayed ipi response might be having some effect.
LindaJanuary 15, 2014 at 8:51 pm #63067JonathanParticipant
I was at SCRC yesterday, getting my ADC infusion (every 3 weeks, but will be there next week for a check-up as well). I’ve been on it with good results for a little over 6 months now (separate series of posts you can look up on my history). Get my email from Catherine if you have any particular questions. I was on the highest dose (2.8 mg/kg) no longer given, now reduced to 1.8 because I developed some peripheral neuropathy at the high dose. There are at least 2 other patients currently on the drug there on Tuesdays, so we’ve got a little club going. One lady has been on it for 20 months with stability after a nice early reduction (that’s the pattern).
Welcome to the club,
P.S. Yes, Dr Infante says they are NOT going to expand sites, and have almost closed the admissions of new patients to the places it’s open. Hard to know why, since it is very promising. No quotes on response rates, but I think it’s pretty high.
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