Moving forward with the Iovance TIL trial

[LexieCat]

Thought I'd start a new thread to document everything related to the trial. 

I had an appointment this morning with Dr. Bauml, my regular oncologist at Penn. We talked about this trial (which is at MD Anderson/Cooper), and his only lingering concern was whether I was OK with the chemo to deplete the lymphocytes--far stronger/more intense than the chemo I've had so far. I noted I'd be in the hospital for that, so at least it wasn't like I'd be having to take care of other responsibilities. I also said, I assume that if I weren't doing a trial at this point, the next line of therapy would, itself, involve another, probably more intense line of chemo? He agreed. He said, if you're up for it, I think you should go for it. He thinks it's a really interesting study, though he personally thinks CAR-T cell research is more promising overall. As for the other trial at Penn, he felt that if I was sure I wanted to do the one at Cooper I should just focus on that for now. He said if something goes wrong where I can't continue with that trial for some reason I can drop him a line and he'd work on getting me set up with another trial.

He also told me he had some "difficult" news to share--he's leaving in July to take a non-clinical, research position with Janssen Pharmaceuticals. His passion is really research and this is within driving distance for him. So I can't continue to be treated by him in any event after July. And as long as the trial treatment is working, I really won't need much in the way of treatment, other than scans and my Zometa infusions once every three months. 

I have an appointment on Tuesday with my favorite surgeon to start the process for the surgery. Cooper was unable to access the actual images from my most recent scans, so while I was seeing Dr. Bauml, I picked up the disc, which I then dropped off to the research nurse at Cooper so my surgeon can have a look before my appointment next week.

As with most things, it's making that initial decision that's tough. Now that I've decided, I feel committed and kind of excited about the whole thing.

[Sandy N]

Thanks for the update, Lexie!  I hope this trial proves successful.  Without people willing to participate in these, we wouldn't be where we are now with all the new treatments popping up right and left.  Thank you for your willingness to do that.  How long will you have to be in the hospital?

 

[LexieCat]

7 minutes ago, Sandy N said:

How long will you have to be in the hospital?

2-3 days for the VATS wedge resection (as normal for that procedure) and somewhere between 1-2 weeks for the treatment phase.

[Jesse L.]

So, being naturally curious, I had to look up CAR-T research to see what that was, just as a comparison to perhaps the proposed treatment that you'll be getting. 

From what I gather CAR-T cells are out of body engineered immune T-cells that are re-introduced back into the body to specifically attack certain types of cancer. In essence, while a treatment such as this is an immunotherapy, it is more a customized immunotherapy than anything else. Currently, there are FDA approved therapies for (what I gather) most if not all types of lymphatic cancers. The success rate for this type of therapy is over 90 percent for complete elimination of all cancer with the only drawback being the cost at north of $350,000 per person. However, that cost was approved to be covered by Medicare and Medicaid way back starting in 2019 for eligible individuals.

So, given the above, I can see where the thought process is for the clinical trial that you will be a part of. Your trial then I guess, in my own uneducated words, is merely an extension of the same principles used in the above, but just on a more personal level. Oh, and also for NSCLC rather than other types of cancer. Given the above I see no reason why it should not work splendidly. If the medical community can engineer T-cells so specifically, then in my lowly estimation again, there is no reason that you shouldn't come out the other side of your trial in wonderful shape.

And yes there would be that concern about eliminating your lymphocytes prior to infusion with the engineered T-cells, but then I can understand why they would do that. They probably want to make sure that any potential cancer elimination is due to the proposed treatment rather than any other factors. But then according to the study parameters, you'll at least not come out any worse than going into it. 

So in the true spirit of an extremely qualified participant study animal you boldly volunteer for experimentation. I think you've got a damn good chance of coming out of this smelling like a rose and if I were you I would do it too.

And know too we're pulling for you...heaven knows the life you save with your endeavor into the unknown may by be mine!! Such is my humble input from the Midwest where we still use leeches for treatment!! I'm sure you'll keep us in  the loop... 

[LexieCat]

7 minutes ago, Jesse L. said:

I'm sure you'll keep us in  the loop... 

Yeah, I plan to use this thread to document how this trial progresses. I just got an email from the nurse re all the testing that needs to be done prior to surgery. I'll be hearing from the various departments to schedule them:

• CT of pelvis and MRI of the head;
• Laboratory tests and EKG- including blood and urine;
• ECHO cardiogram, exercise stress test;
• Pulmonary function tests.

 

[Jesse L.]

And it is just beginning, but then if anything if you don't already know your body better than nearly anyone else, you certainly will during the process you'll be going through.

You would be surprised at how many self proclaimed rough and tumble guys I know that will proclaim loudly that there's nothing wrong with them. But then they never go to the Dr. either... If you question them on it they'll gladly tell you that Dr.'s are only good for telling you there is something wrong with you (duh?!). Therefore, they don't go to the Dr. and they're just fine?!?! Honest to God that's what counts for genuine logic to a lot of older men here in the midwest. Funny thing about that though is that all of a sudden, the men who think that way just aren't there anymore. And when you ask what happened, you're just told they died unexpectedly. Most usually this happens to men anowhere from 50 to 70; all of a sudden just poof...and gone! 

Not this guy though... I'm going to continue clawing and scraping till I hopefully get to at least the average age of death which, by the way, per AARP is now 77.8 years old. It was higher but it's dropped nearly a year in the last year due to COVID-19 and increased rates of death due to drug overdoses. 

[LexieCat]

Pretty sure I had all of these tests before my lobectomy four years ago. There will be some additional labs collected specifically for the trial, but the rest is pretty much standard pre-lung-surgery testing. Oh, the cranial MRI I didn't have before, but that would be to make sure I don't have brain mets (which would disqualify me from this trial, I believe).

[LexieCat]

@Jesse L. (and anyone else interested)--I found this article, which explains the difference between different ACT (adoptive cell therapies), which includes both TIL (tumor-infiltrating lymphocytes--the treatment I'm getting) and CAR-T therapy, as well as another treatment called TCR (gene-modified T cells expressing novel T cell receptors). I haven't read it yet, but it looks like they are closely related but different therapies:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6447513/

 

[Tom Galli]

Lexie,

Keep us updated if you can while you are hospitalized. We worry when members drop off the grid while in treatment.

Stay the course.

Tom

[LexieCat]

Oh, I will--at least, as I feel up to it. I've been warned that there will probably be several days where I'm completely wiped out. It will be a few weeks before I go in for that part of it. The surgery should only be 2-3 days.

 

[Saturn_Bound]

Good luck and I am rooting for you!

I called to see if my mom would qualify, but they said because she uses supplemental oxygen (a couple times a day) and cannot do normal tasks for a majority of the day, that she is too “frail” and would not qualify ;/

[LexieCat]

Yeah, it really sounds like this treatment is pretty brutal, so it wouldn't be a good fit for her--they never want to harm patients in a trial. There are other trials out there, though. It might be worth looking into others.  

[LexieCat]

I just thought about it, and I noticed that they weren't ordering a CT for the chest, but rather just the abdomen/pelvis. I just messaged the research nurse to say, you know there's a scan of my abdomen/pelvis on that disc I dropped off yesterday, right? In addition to the chest CT? She messaged back (yes, at 7:30 am) and said, THANKS--great catch, no, you don't need to have another pelvic CT done--the one you just had is sufficient. She said I was an "awesome patient" to be so alert for things like that.

Once again, it pays to double-check ANYTHING that seems questionable. It probably wouldn't have hurt anything to have another CT, but why have a procedure (and additional radiation) if I don't need it? 

I also checked on discontinuing my prescription for the dexamethasone (since I'm not continuing with chemo right now) and was told I can cancel that for now. 

[Lisa Haines]

I am looking forward to following you through this trial and find it very interesting, so thank you for sharing all the information with us!    I wish you the very best and hope this will be a total success!

   ~ Lisa

[LexieCat]

I talked with my son this morning (daughter was tied up so it may be this weekend before we connect) and I could tell he was a bit worried about how daunting this trial would be.  But I think he understood my reasoning, once I explained it. This may be my best/only shot at actually wiping out my cancer--for all and for good.  I know there are lots of other available treatments (including trials) out there that I can try. Who knows, maybe one of them would have the same result? But this seems like my first, best shot at TRYING for a cure. I passed on curative treatment the first time, since everyone thought the radiation would be too tough on my esophagus. If this fails, oh well, I tried, contributed to research, and will have to move on to another treatment. But if it WORKS...

[Jesse L.]

As I've stated before, I understand your reasoning for participation 100 percent. At least it seems that you can't come out any worse than you went in... For me cancer seems to have taken over a significant share of my life and I would easily do as you to stop that. And that's even with tests finding no growths anywhere in my body. But then again, where is it hiding/lurking, watching, waiting, till when you least expect it will pop up again; always transforming to evade the latest poisons we throw at it... And then too, what if it's a one off and you'll be good for the rest of your time on Earth?!?! It's the not knowing that gets a person. For the personally unaffected it is nearly completely impossible for them to understand.

Oh no, I get it... More power to you and I'm behind you for all that's worth!

  

[LexieCat]

At the suggestion of Rower Michelle, I called Andrew from the Go2 Foundation to run the trial by him. Just one more expert to weigh in to make sure I'm not overlooking any relevant considerations. 

Andrew was very nice and helpful. He didn't really identify any concerns I wasn't aware of, but still--the more brains that weigh in on a decision like this, the better.

I recommend Andrew and the Go2 folks to anyone wanting to look into a clinical trial.

[Rower Michelle]

Good!  I'm glad Andrew was of some assistance.  Like you said, it's a big decision to move forward with this trial.  In some respect, even though Dr. B will be joining the Johnson & Johnson research family, we are all going to benefit as the science advances.   Cellular therapies are the way forward and now you are leading the way, for that we're so grateful you're willing to do this.     Let us know how it goes with your daughter, one kid down, one to go....

[Jesse L.]

Hey, I just read the article you mentioned in a previous post and it did clear up some questions in regards to your trial. There is some risk with them removing your lymphocytes prior to infusion with the engineered CAR-T cells, but I'm sure they'll be watching you like a hawk.

For the most part the VA watches me like that too and that really can be a pain. Since they put me on ELIQUIS on last Monday night I have gotten calls from my nurse navigator at the Green Bay VA, my Oncologist from the Milwaukeek VA, and even some nurse I never heard from before from my VA PCP office at a completely different location. They all want to know how I'm doing, etc, etc, etc (not to sound like Yul Brenner in "The King and I" mind you). I never get a chance to get away from it all...they're always there!!! 

Nevertheless, I wish you well...just remember the life you save may be mine...I'm sure that's all you'll need to stay motivated...lol!!

[LexieCat]

6 minutes ago, Jesse L. said:

There is some risk with them removing your lymphocytes prior to infusion with the engineered CAR-T cells, but I'm sure they'll be watching you like a hawk

They will be watching me carefully. Remember, though, CAR-T cell therapy is something different. I'm getting TIL (tumor-infiltrating lymphocyte) treatment. That article I linked to, in the post where I mentioned your name, describes the differences between the two.

[LouT]

Lexie,

I'm reading this thread and I fully understand your reasoning for participating in this trial.  The "once and for all" part of the recovers is a big deal and you're smart to do it while you're strong enough overall to withstand it and reap the fullest benefit.  I look forward to your updates and will keep you in my prayers.

Lou

[Jesse L.]

Oops...my error...but at least I'm on the right path. I did momentarily mix up CAR-T cell therapy with the TIL therapy that you will be getting. It's sort of easy to mix this up in that a lot of the techniques used in each of the therapies are quite similar. I would imagine that the most important part is the customized part of the immunotherapy. That reminds me so much of targeted immunotherapies currently in use for actionable mutations, but even being much more effective in that T-cells are engineered/programmed to destroy the cancer cells as they are right now. This should alleviate waiting till those cancer cells morph into something those T-cells either fail to recognize or just can no longer destroy.

Why does this remind me so much of COVID-19? I would guess it is because cancer seems to act in sort of the same way that the virus does. However, in the case of cancer variants, they occur on an even more personal level to remain alive despite whatever we throw at it within our own bodies. So, the point is to kill it quickly, before the cancer can adjust to the created therapy. 

This is even much more important in terms of therapy with regards to those with no actionable mutations because if it does work for you (and others in the same trial I'm sure), then it will work for anyone. An endeavor well worth working for and on...  

[LexieCat]

Now that I've decided I want to go forward on this trial, I'm trying to make sure I don't have any issues that will knock me out of it. I have a treadmill, which I haven't touched in months because of hip pain and--let's face it--my natural laziness. So I looked up the protocol for the stress test I'll be doing next week, to see how I'd make out. I did OK up to the last leg, where I had to stop after a minute and a half (out of three) because I just couldn't walk that fast anymore. Given that they are concerned with heart rate, I think I will be OK (gonna try to do it once/twice a day in the meantime). I've  just been WAY too sedentary. They are also having me do the recumbent bike at PT, which should help, too. 

I have an oximeter I bought several months ago, and my resting heart rate is around 70, which supposedly is good. My oxygen level is consistently 98-99 percent.

So considering I have Stage IV lung cancer, and am pretty out of shape and have gained weight, I think I'm doing OK. I just have this nasty tumor I need to kill.

Oh, and I looked up the effects of the chemo drugs they will give me to knock out my immune system, and holy crap. The consent form listed them, but in the articles describing them, they sound even more unpleasant. For the first two days I will get Cyclophosphamide and for the first five, Fludarabine. I decided not to spend money on getting my hair cut till I see how much hair survives this thing. Apparently these drugs are so toxic they are given only for a very limited time period, and mostly for the purpose I'm getting them--to wipe out the immune system. I do think, though, this is the time to try something like this--when my health is otherwise reasonably good.  The clinical nurse said I probably wouldn't feel too terrible the first few days (which she said might be "pretty boring"), but then I'd start feeling the effects. One of the effects is bleeding in the bladder, so they will also give me a drug called Mesna that's supposed to prevent that.

 

[LouT]

Lexie,

A resting of 70 and O2 of 98-99 are both indicators of good cardiac fitness and pulmonary function so you seem okay there.  You are wise to focus on your endurance.  That is usually the first thing to go when you haven't kept up a workout routine, but you can turn that around pretty quickly.  You could go out for a walk and vary your pace (something like HIIT but modified) and do it often during the day.  When I walk in the morning I vary my speed between 3mph (dog-walking speed) to 4mph (light jog) and sometimes, on the treadmill, I push it more to between 4-5mph.  But in your case you can get good results with the slower-quicker-slower approach.  And, I will say, that for someone who says they don't workout your vitals seem very good.  I do 5 miles/day for 6 days/week and my resting is only 5 beats lower per minute while my O2 is between 97-98.

You can do this and if you take the multiple shorter walks per day you'll see improvement more rapidly than you expected.  Best of luck on the test and in this quest to kill that sucker of a tumor.

Lou

[Judy M2]

So sorry to hear you'll be losing Dr. Bauml! This trial sounds very interesting, and I hope you can tolerate everything they'll be doing to you. Those chemo drugs sound heavy-duty but it's good you'll be closely monitored. Best of luck on the journey.