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Hi All,

I had a question about clinical trials. Basically:

1) How to get involved? I tried calling 1 or 2 and got helpful responses, but I'm not really sure if this is something I should be doing myself or if our oncologist should be involved.

2) How to pay? Are they normally covered by the organization offering the trial or does insurance normally cover them? There are a lot of them offered by institutions outside of my  Mom's HMO network, and none of them discuss anything about payment.

3) Role if any of your regular oncologist or team of doctors.

The context is this: My mom who was just diagnosed with SCLC is starting off with conventional chemo (and perhaps radiation). There's no particular need it seems for a clinical trial for phase 1...that would delay her care (and she is only starting chemo 5 weeks after diagnosis anyway), there are very few first-round trials for SCLC and given that the first round is typically highly effective and my Mom's cancer is very limited, there didn't seem to be any reason to do it right now. Seems like it could be very important for round 2 though...most stories I've come across of long-term survivors seem to have gotten good traction out of a clinical trial at some point.

However, before we had the full info on the plan of care, I did research and found that there are A LOT of phase 1, 2 and 3 clinical trials in our area (NYC), and I gathered the full list. I researched which ones my Mom would be eligible for and summarized each one.

Unfortunately, I was pretty disappointed with the reaction of my Mom's two oncologists. One was very negative on all of it and seemed to try to push us into her first round trial even though that would delay my Mom's treatment up to 6 weeks. She also made some other questionable recommendations like NOT getting a PET scan (even though the other doctors and literature all seem to think this is very important). So, we decided to stop seeing her. The second doctor (same medical group) is better in general, but on this topic it was frustrating to deal with her. I let her know that I have no idea how to go about doing any of this, and she was so cagey...trying to get info out of her was like pulling teeth. When I asked her how to determine which one was right, she just said "contact them and talk to them." When I asked her which ones seemed interesting or promising based on the sorts of drugs they were trialing and any past/similar research, she seemed hesitant to answer and basically said she thinks this "Rova-T" drug is promising and that we should consider anything involving that. I can't remember exactly what was said otherwise, but it just seemed that essentially if we go into a trial we will no longer be under her care and therefore she didn't want anything to do with it because we were going elsewhere.

Is this normal or are doctors normally more collaborative on this question?

How should I go about short-listing those to keep in mind for round 2?

I've seen a few recent promising drugs in various clinical trials...has anyone heard of anything through the grapevine as to whether or not these are anywhere near showing actual results? Some examples here, but I also attached the full list I found.

EZH2 Inhibitors: https://www.mskcc.org/blog/scientists-home-treatment-advance-chemotherapy-resistant-small-cell-lung

Rova-T: https://adcreview.com/news/rovalpituzumab-tesirine-shows-early-promise-in-small-cell-lung-cancer/

Pentaris: http://www.digitaljournal.com/pr/3645959



Clinical Trials.pdf

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You've posed a very complicated question.  My answer is based on my experience.  Consider that each of us is unique and therefore there may be many individual-centered criteria for either joining or not joining a trial. As for where to find information about trials, most cancer research hospitals post their current trial information on line.  Here is the information MD Anderson has on its current trials.

How did I get involved in clinical trials?  My two involvements, were both suggested by doctors, my surgeon and oncologist.  They review the literature describing a trial and patient criteria and determined if my case fit the criteria.  Then they recommended I consider the trial.

How is payment involved?  In my experience, payment for all drugs and procedures used in the clinical trial, including all medicines or treatments to deal with side effects, was covered by the institution providing the trial.  I had to sign a disclaimer that was very clear stating I had to report all side effects to the trial medical staff and seek treatment only from the trial medical staff.  I also had to report all other medical treatment I received to the trial medical staff, for example, a sore throat or chest cold.  Moreover, I could not seek treatment from my current team of cancer providers while enrolled in the trial.  These limitations were very important discriminators for me.

What was the role of my regular oncologist or team of treating cancer physicians?  My regular cancer treatment team would have been superseded by the trial medical team.  This was part of my reasoning for not accepting the first trial recommended for me.

I did not join cancer trials during my treatment.  I did receive two treatments that emerged from trial and received FDA approval so trials are important.  But, in my case I decided after consulting with all my doctors that trials were not in my best interest.  I found the opinion of my general practitioner to be a very important prospective to evaluate and help me decide on the efficacy and applicability of the trial.  The GP was a neutral practitioner.  He did not provide any of my cancer treatment and therefore could wade in and provide an unbiased opinion, and he did.

I am sorry you are having difficulty getting answers from your mom's oncologists.  Fortunately, my oncologist always posed a range of possible solutions for my wife and I to consider.  I'd discuss these ideas with my general practitioner.  He would explain the medical circumstances in a way we could understand, then I'd go back to my oncologist for further discussion given the insight of my GP and make a decision.  

I found my treatment team to be very collaborative.  What made it so was they were selected by my general practitioner.  So, they had worked together and knew one another.  My GP made many referrals to this team over the years, and therefore, my cancer treatment team knew he'd be involved and welcomed the involvement!  I believe my general practitioner and his counsel was very instrumental to my treatment success.  Consider, however, that my active treatment took place 14 years ago.  Medicine has changed in that timeframe.  Many people do not have general practitioners but use minor illness care clinics as alternatives so having that neutral resource may not be possible in today's medical environment. 

I don't have any idea how you should evaluate and short-list potential trials.  I do note the link you posted on EXH2 Inhibitors has information provided by Dr. Charles Rudin, a member of LUNGevity's board of directors.

I hope I've answered all of your questions.

Stay the course.


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Hey Tom,

Thanks a lot as always. 

My Mom's team is all at NY Presbyterian (Columbia and Lawrence), so they generally know and like each other. However, just on this clinical trial question the two oncologists seemed very cagey. I think I will try to discuss this with them more explicitly once we move forward a bit with the initial chemo and see how she does with that (it starts tomorrow). 

I actually already contacted Dr. Rudin for a second opinion and though I didn't speak to him directly, his nurse recommended standard treatment to begin with given my Mom's relatively good condition and the typical efficacy of first-line chemo on SCLC. She invited me to contact her back for the second line. I guess my question is when to do that. Supposing all goes well and my Mom gets a full response (NED) or very positive response to the chemo + radiation, I'm not sure if we'd right away want to plan the second line or wait to see if the cancer stabilizes. In general, I'd feel more comfortable having a plan in my pocket before we have to execute it, but I don't know if that's realistic or how this is done...I'm a newbie to cancer! My worry is if I wait until the second line is needed to arrange something, it could lead to a delay in her care because some of those trials take time to join.

My Mom does have a GP who she has been a longtime patient of, but having talked to him I'm not so sure how much of this stuff he understands. However, that is a good suggestion - it wouldn't hurt to talk to him.

This was super-helpful. I suppose what I will do is continue to reach out to some of the interesting-looking trial administrators myself to get more info on them as well as insurance info, and at the same time press my Mom's oncology team for more answers as we move through the chemo.

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You might start second line discussion after the results of her mid-treatment scan.  Alternatively, I agree that given lung cancer's persistence and SCLC rapid metastatic behavior, planning for second line now might be a good idea.  I'd certainly check all the cancer research hospital websites to learn about potential SCLC trials. You might need to do a little Googling to look up medical terms but that's not too difficult.  I'd make a spreadsheet of all the interesting trials along with the web address of the html page.  Then, I'd discuss each candidate trial and if you have a web connected cell phone, bring up the webpage and show it to the doctor.

Your mom's GP won't be a subject matter expert on cancer but I'd venture her or she's seen a lot of patients.  They know the good providers from the not so good.  They also know enough to understand trial medical eligibility criteria.  Many trials have general health eligibility criteria and your mom's GP will certainly know about this information.

NY Presby has a good reputation from the checking I've done.  Perhaps you need to have a joint consultation including both cagy oncologists to move the ball forward.

Stay the course.


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Haha I beat you to the punch! 

I compiled the attached spreadsheet last week.

Thanks for your advice. I will talk with her GP once we see some progress reports from chemo. She went today. I know it tends to have a cumulative effect, but no side effects whatsoever yet. Gotta take the small victories where they come I guess!

Clinical trials pdf.pdf

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Just an update. We've now completed one round of chemo, and the doctors are hoping to do a minimum of four. I know some of the effects are cumulative, but it's pretty remarkable - no side-effects whatsoever. She is functioning at her usual (high) level. She's a bit bloated from the steroids, but that started even before the chemo.

I know it won't get any better, but this was a big relief for me and a small victory overall. We can enjoy the next 2 weeks before the next round at least.

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Fortunately for me, I don't have to worry about treatment protocols/trials/etc., at least for the time being.  I just wanted to say I think you are approaching this in a very sensible way, and appreciate your sharing your thought processes.  You do ask great questions, and this thread has been educational!

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