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Clinical trial decisions


LexieCat

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So after getting more info on the two trials at Penn, I'm thinking that the one involving the injection into the tumor (which requires two biopsy/injections, each followed by 14 days of oral antiviral medication, along with the same maintenance therapy I've been getting) is more appealing than the first one I heard about (the one involving weekly infusions of the new CAN04 and periodic infusions of Keytruda)--the idea of having to go through weekly infusions for an investigational drug isn't an idea I'm wild about. The injection-type one has mostly been tested in glioblastoma patients, but apparently the response was pretty good. 

I still hadn't heard back from MD Anderson/Cooper re the autologous immunotherapy trial, so I sent a text to my surgeon there who did my lobectomy, as well as having the telephone operator send a detailed email to the research department, specifying which trial I was interested in. A research nurse from Cooper called me, and she had already gone through my records (they can access my treatment info at Penn through the linked portals), and she said I was disqualified due the type of immunotherapy I'd gotten. So she commiserated with me and then mentioned I was also ineligible because the trial required liver mets. I said, "Wait a minute--are you sure we're talking about the same trial?" I gave her the trial NCT identifier and we confirmed she was talking about a completely different trial from the one I was asking about.

So now she needs to go through the info for the RIGHT one and call me back. 

*sigh*

Nothing is ever simple.

OTOH, my lovely surgeon asked me if I wanted someone from his team to give me a call. He's the BEST. I told him to wait till the research nurse called me back & I'd let him know. All things considered, I'd sooner be treated at Penn than at Cooper again, but the trial involves a single course of treatment--one infusion of this manufactured immunotherapy--so I imagine I could have any further treatment back at Penn. 

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So after a few hours, she calls me back, having reviewed the criteria for the RIGHT trial. NOW she says I'm ineligible because the trial requires that I be negative for ALK, EGFR, ROS1, and a couple more mutations. I tell her, I AM negative for all those. She says, not according to your doctor's notes. 

Turns out she's looking at a note that lists a bunch of mutations, followed by "wild type." I tell her that means NO mutations, and she's not convinced. I tell her I'll have my oncologist email her. After we got off the phone, I found my molecular testing report (which for whatever reason had not been scanned into my records). I scanned them and sent them to her with an email saying, "As you can see, I'm negative for all of these markers." *facepalm*

Haven't heard back yet. 

Another illustration for why it pays to double-check what the doctors/nurses are working from. But I found it rather disconcerting that I'm having all this trouble just getting my eligibility confirmed. 

Thankfully, I was able to confirm with Penn that even if I go with this trial (which involves a one-time treatment after the tumor sample is harvested), I can be followed up by Dr. Bauml.

 

 

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I have faith that if anyone can make the "right" decision it will be you. Of course that will mean that you will have to make sure that everyone is on the same page, the right page, and that they're taking account of even the right person. Unfortunately it doesn't surprise me that you are having to do that. When I read what you write here, I get frustrated; I can just imagine how you feel. 

If anything though I know you will persist... You are apparently smart and have proven that you will not give up nor give in. Keep it up...you have my support!! 

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  • Frustrating for sure! You'd think that the nurses working on these trials would be more orrganized and better informed. This kind of stuff makes me want to bite my arm!  
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5 hours ago, BridgetO said:
  • Frustrating for sure! You'd think that the nurses working on these trials would be more orrganized and better informed. This kind of stuff makes me want to bite my arm!  

A new one on me--arm-biting. I guess that's a step up (or down) from tongue-biting!

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My lovely surgeon just called me. He personally reached out to the head of the research department, to grease the wheels here. She will personally call me in a bit to set up an appointment for an eligibility evaluation.

He did tell me that from what he knew of this trial, it was pretty drastic treatment. As I surmised from the description, it's almost like a stem cell transplant--they completely deplete your lymphocytes before infusing the custom immunotherapy.

I thanked him profusely for his help--this is the second time he's cut red tape for me since I was done being treated by him. I have his personal cell phone and he's told me to call him any time. When I told him I hated to bother him, he said, well, then text me. I try not to abuse it, but he tells me how glad he is that I'm keeping him in the loop. We really hit it off--I'm so glad he's in my corner.

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Lexie,

That ordeal you've been through... so frustrating!  Don't you just wish people would do their jobs thoroughly?  We (as patients) always seem to have to follow-up, check for accuracy, making sure everything is right.  Glad the surgeon called you.

Deb

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He was rather dismayed to hear about my experience and assured me he would let the research folks know what happened. The first screwup wasn't necessarily her fault--it sounds like the operator who sent out the email might not have gotten the trial number right. But misinterpreting typewritten notes (even I know what "wild type" means) and telling a patient they are excluded from a study for which they might be eligible is something that just shouldn't happen.

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The head research nurse at Cooper called as promised. She thinks, preliminarily, that it looks like I might be a good candidate for the trial. She sent me the informed consent form and will try to schedule an evaluation appointment with me for tomorrow. 

In the small world department, she was my surgeon's nurse navigator when I had my lobectomy, and she previously worked at Penn with my current oncologist. We agreed they were two of the best doctors we've run across. 

There are three main concerns I have--delay before treatment, surgical procedure to obtain a sample of the tumor, and the lymphocyte depletion required before the infusion.

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Lexie,

On your concerns, delay before treatment is certainly an issue but as I understand it, your progression, in terms of tumor size increase, was small. The surgical risk is always there, for any surgery. A surgical biopsy risk element would likely be associated with the risk equal to general anesthesia. Purposeful lymphocyte depletion does sound scary. As I understand it, your white blood cells need to be reduced substantially for the trail drug to work. This of course would mean you'd need to be isolated for a time to avoid catching anything from a simple cold or worse. Are they proposing medical isolation in a hospital as a mitigation strategy?

After infusion, will there be a restoration of lymphocytes or do you need to stay isolated?

Stay the course.

Tom

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Right, those are the kinds of things I want to find out about. I had to go out for a dental appointment, so I'm just starting to go through the informed consent form.

I asked the nurse at Penn whether I could be evaluated for two trials at once and she said she'd ask my oncologist but she thought patients could only be evaluated for one at a time. If that's so, I might sign the consent for this one just because of the lead time issue. It's primarily my oncologist who's concerned about the lead time. He doesn't seem to think it's a deal-breaker, but something to be concerned about.  It sounds like it would be about six weeks from signing onto the trial until I'd actually get the treatment. And, of course, it's already been over three weeks since my last treatment (since the most recent one was canceled).

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I've got an appointment to meet with the lead investigator/surgeon tomorrow at 12:30. 

I'll bring a list of all my questions and concerns. 

According to my surgeon, this doc is terrific. 

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So many choices and so many questions...well, not really that many, but it's tough to make the best and right decision that would be in your own best interest. You stated before that although it's all well and good to be altruistic, deep down we try and satisfy our own best interests.

As I have stated before though, I have every faith that you will ask all the right questions and make the best decision. I'll be interested to hear of your experiences in the trial...

I have every faith that if at all possible you will do well. 

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LexiCat - I'm just getting caught up with your situation.  It sounds like your immune system and blood cells (red, white, platelets) may be affected by this proposed treatment???  If so, feel free to reach out to me, my mom's leukemia treatment resulted in neutropenia with all 3 doses.  She pretty much had no immune system for 4 months and is now in the same boat due to relapse.  There are simple precautions to take that all leukemia patients and their caregivers are given.  If you end up going that route, I can give you some information based on my mom's treatment.

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So I met today with the doc running the study at Cooper. I got every question of concern answered to my satisfaction, I signed the consent form, and unless something unforeseen comes up, I plan to participate.

Here's a diagram of how this trial works: https://www.iovance.com/wp-content/uploads/AACR_2021_ePoster_IOV-LUN-202_TiP.pdf

The initial surgery to harvest the sample of my tumor would be a VATS wedge resection--and the surgeon would be my favorite surgeon! I'd be in 2-3 days (and hopefully without the crepitus that got me last time). After that, they send the sample off to have a customized immunotherapy manufactured--that takes about 3 weeks.

About 5 days before the immunotherapy drug is ready to be infused, I would be admitted to the hospital for the chemo to deplete my lymphocytes. That takes about 5 days. Then the custom immunotherapy is infused over the course of a couple of days, and then it's topped off with infusions of IL-2, which apparently gets everything revved up.  The doc says I wouldn't be discharged until my immune system was back to normal (albeit new and improved).

One of the biggest upsides to this is that IF it works, that's it, in terms of treatment. No more chemo or other drugs, at least until something changes. 

To me, it seems worth the shot. 

I'm seeing my own oncologist tomorrow morning for evaluation for the other (tumor-injection) trial, just in case something goes wrong and I can't complete this one. I'll let him know what I found out, and the research nurse at Cooper used to work with him at Penn. She told me to have him call her while I'm there if he has any questions about this trial. 

I think it's sounds super-exciting. :) 

 

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2 hours ago, Steff said:

LexiCat - I'm just getting caught up with your situation.  It sounds like your immune system and blood cells (red, white, platelets) may be affected by this proposed treatment???  If so, feel free to reach out to me, my mom's leukemia treatment resulted in neutropenia with all 3 doses.  She pretty much had no immune system for 4 months and is now in the same boat due to relapse.  There are simple precautions to take that all leukemia patients and their caregivers are given.  If you end up going that route, I can give you some information based on my mom's treatment.

Thanks, Steff, I appreciate it. But it looks like I'll be hospitalized in the oncology unit the whole time my lymphocytes are depleted, so I'll be under medical supervision the whole time by experienced oncology nurses.

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Wow...custom immunotherapy!! That is some interesting stuff. There seems to be quite a bit of prepwork, but if it works in the end it will be well worth it. And I'm sure too that they'll be watching you like a hawk throughout, especially with what they'll be doing to your system. Maybe perhaps what youre doing will benefit so many more... I wish you the very best of outcomes with it. 

And let us all know about every step of the way... I for one am genuinely interested. Please remember that I don't have any actionable mutations either...your actions just may save me someday!!

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Lexie,

And to think that if you didn't question and push back against people with hard, deep knowledge about your condition you wouldn't even have made it into the trial.  What a lesson for all of us.  I, personally, am guilty of not reading results and deep-diving into my present condition, but rather just following what my docs have said my condition is.  We all need to be well-aware of our condition so that we can avoid inept actions by medical staff that can affect our treatment, outcomes and lives.

Thanks for the great example you set and your direct and informed way of "keeping the facts straight".

Lou

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Lexie

As always...I'm rooting hard for you!

Curious if you happened to ask your Team about the Novocure medical device I posted about. Not questioning your plan, just curious if he had heard of it.

Another good news release yesterday...and the stock is reacting really well to the news. As they say..follow the money.

Looking forward to how your trial goes. Your initial treatment to knock out your immune system sounds very similar to what my son went through years ago for Aplastic Anemia. Basically....they totally shutdown his bone marrow. ALL his counts dropped precipitously and he had to have transfusions...especially for platelets. The theory was to reboot his immune system. Son of a gun....it worked! Not a favorite time in my life but the kids completely fine now. He was in a clean room for about 10 days as well.

Peace

Tom

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I asked Dr. Bauml about Novocure and he wasn't that impressed, apart from the glioblastoma results. He wasn't convinced it would be effective (as opposed to safe) for lung cancer. But we'll see--that's why they have trials. Interestingly, I was on the phone the other day with my investment people from Morgan Stanley, and the one guy on the call was very familiar with Novocure. No doubt about it, the market loves it. But the market isn't infallible, either, lol. It's interesting for sure, and even if all it really works for is brain cancer, that's still a huge win.

Great news about your son, though. There are a few cancer treatments (generally of the transplant variety) that involve shutting down the immune system. I'm so glad he's doing well new. 

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