Trials: How to Pick them, How to Do them

blainejennifer

Dear All Who Have Done Trials:

How did you navigate choosing the trial? And, having chosen, how did you manage the logistics?

I'm in a small town in upstate NY, so any trial I'd participate in would require travel, lodging, and possibly, nursing oversight. The two trial coordinators I've talked to are lovely people, but they have no systems in place for "out of towners".

I'm also coming to realize that if you are poor, you probably won't get to do a trial.

I could use some wisdom here, as the afore mentioned trial coordinators are eager for me to make a decision. They are both immunotherapy trials, but one has a proprietary process, which means that you can't find out a whole lot about the drug process.

How, how, how do they expect mere mortals to make these decisions? My MO looked through the information and said that they "looked good". Right then.

We need trial doulas.

Jennifer

Daniel86

Jennifer, did you think about starting a fundraising of sort? People are usually very receptive when it comes to causes like this. Maybe that could help you bear some of the costs of lodging and travelling? Are these trials run by big hospitals? While the coordinators don't have anything in plan for out of town folks, the hospital itself might lean on some charity company/have some deal for that kind of stuff.

I can't offer any opinion on the medical stuff but I am definitely curious to know if our science team (I am looking at you Cure-ious, Penny78 and JFL can shed some light. I would imagine any good advice would be of help at this moment.

Daniel

Cure-ious

Jennifer, which trials you are contemplating?

blainejennifer

NCT03272334. I have actually been accepted to this trial.

NCT01174121. This trial wants to see my next set of scans. They have all my medical records, and have stated that I would be eligible, probably, maybe. They are real popular right now, due to the Judy Perkins publicity. I put in with them before all that, but I still might have trouble getting back in the pipeline here.

We have means. It would strain them, but we have been lucky. I would feel disingenuous fundraising, as it might take out of the world money that should go to a person with more financial constraints, you know?

Jennifer

Daniel86

Wow, they both sound really promising. The second one doesn't seem to be targeted mainly to breast cancer. Did they share what percentage of MBC patients they are accepting? Also, I think you said somewhere else you are currently on Navelbine. How does that play into the trial as far as scheduling goes (when do you need to stop and stuff, etc.)

blainejennifer

There is usually a wash out period before collecting what tissue/cells they need for the T Cell conversion process. It varies from 2 to 6 weeks, depending on the trial. For the first trial, they want you off all other therapy for the eight months of the trial. That's great - if the trial is working; if not, that could be a very bad thing indeed.

For the second trial, there is a four month period, after the cell collection and before infusion, and they are aware that you'll need to hop onto a maintenance protocol, at the very least. Then, before infusion, you'd have to wash out again.

The first trial is split between pancreatic cancers, and breast cancers. The second trial chooses you based on how resectable your tumor is, as they need to get non-bone tumor tissue for their magic broth. They love lung nodules, and approved of my easily accessed liver mass. To the best of my knowledge, they've focused on colorectal cancers, liver cancers and breast cancers. The three real remissions they've obtained have been a ER/PR+, HER2- lady, a colorectal patient, and a bile duct cancer patient. It's better than nothing, but the cohort is pretty large. Mind you, no one else can even claim three cures. And, can you say cure? They are certainly NED, with no ongoing therapy, but it's only been about three years.

AussieTracey

Jennifer I am in Australia so I can't speak to the specific trials you are looking to possibly being a participant. However 3 years ago I was accepted into a trial of pembrolizumab combined with targeted radiotherapy. I needed to have less than 5 mets and at least one bone met for targeted radiotherapy. My private oncologist talked me out of that trial as he thought the risks of immunotherapy were out weighed by the benefits especially as I had progressed really slowly and I was Er positive and Her2 negative and triple negative patients seemed to be the ones responding in this trial. I did join another trial Abt 199 which was a leukaemia drug they were investigating for use in oestrogen positive her2 negative metastatic breast cancer. I progressed quite rapidly on the Abt 199 ( ventaclax) trial. Initially it was thought I could swap back to the keytruda trial. I actually probably had to many mets but the other problem was the latest biopsy showed I was now triple negative. I was no longer eligible as I now had both oestrogen positive and triple negative mets. I suppose my point to this story is with trials it is often difficult to met the eligibility criteria and they often can’t be revisited. For me I will always regret not taking the risk with pembrolizumab trial because my tumours were changing to triple negative and I may I have had a good response. I don’t think I will meet trial eligibility criteria in the future as I have had many lines of therapy since then and developed diabetes which excludes me from many trials. I do think immunotherapy is the area that is seeing some long term response. If you have been accepted into one of them I would jump at the chance now. Wishing you all the best with your decision

Tracey

pajim

blainejennifer, I'm not going to comment on the two trials you're looking at but thinking about your original question.

Being in a trial is really hard if you don't live near the trial site. There are long days to begin with, not to mention all the screening and so forth. What you really need is a friend who lives in NYC or in Boston who would be willing to host you for a couple of days a month. Or in your case Charlottesville or DC. The NIH only does out-of-towners. So they should have some hostel or cheap place to stay. [FYI Charlottesville is a gorgeous place]

Cost is another issue. I entered a trial this year to discover that they charged my insurance for all the CT scans. Which means I had to pay the co-pay. That's OK for me as it's only $25 and I'm working, but I have a friend whose co-pay for CT scans is $150!!! She couldn't possibly afford that every six weeks. Does that mean she can't enroll? Ugh!! I would encourage everyone to ask about the ancillary costs of being in a trial.

How to choose? Shrug. I don't have an answer. Sometimes just because it seems like a good idea. I screened for the latest one because my onc was so enthusiastic. He wanted to try pembro whilst the going was good. I'm going to fail the screen for most pembro trials [had pneumonitis last year] so we'll look at something else next time.

OK I did look at your trials. I like the one at NIH better. They're on their 4th cohort and it must be working (in general) or they wouldn't have made it to cohort 4. Did you ask the UVA guys how many patients they've treated so far ans how it's going? But a bird in the hand is worth two in the bush.

Daniel86

Bump!

Jennifer, how are things coming along?

blainejennifer

Daniel,

Both trials want to see the CAT scan I'm going to have Friday. I still don't know which trial is better. I am leaning towards the NIH one, and I don't know why.

Thanks for asking,

Jennifer

Daniel86

Hey Jennifer!

What did you end up doing? How are you otherwise?

blainejennifer

The choice is in their hands now. I've put in all the paperwork, and will contact them when I start failing out of Navelbine.

How am I doing otherwise? The Navelbine is working, but I have a lot of abdominal pain associated with it. In a way, I'm looking forward to failing out of this one.

How goes it on your end?

Daniel86

Glad to hear Navelbine is working even though I understand those SEs are an effing drag! Have you thought of trying the holistic route through a naturopathic oncologist? Maybe they can suggest some supplement that could help!?

On our end, nothing much is moving. Today was one of those days when the word terminal was thrown around too much and it just makes everything gloomy.

Daniel

blainejennifer

Daniel,

We are trying various maneuvers. The problem is that I have gallbladder disease, and can't find a surgeon that will touch me due to being so heavily pre-treated. It doesn't show up on scans, or in the bloodwork, yet still hurts like heck. Good times.

Who's bandying about the T-word? Gloomy is right. I think I will prefer euphemisms when it's my turn.