Risk vs reward in clinical trials

[Pmann]

Morning folks,

I just finished reading my clinical protocol consent paperwork and don’t get the good warm feeling that the risk is worth the reward.

This trial is through Sarah Cannon Research and involves a first in human investigational drug called TAK 280. It utilizes an approach already in clinical use to attach T cells in your body directly to the cancer cells.

Being first in human is somewhat scary when they can’t say for sure if you will receive any real benefit from the treatment.

It is also quite arduous in that it requires weekly infusions for 14 months and I am almost a three hour drive to the clinic.

I wonder if I pass on this trial if I get black balled for others.

Thoughts and advice are appreciated.

[Avanat]

My husband was in a Phase 2 clinical trial sponsored by Dana Farber but administered at Moffitt Cancer Center. He was told if he opted out he could still participate in others down the road. It was supposed to be a 2 year trial but he was taken out of the trial by his oncologist after 8 months because of side effects. His doctor was worried about the side effects becoming permanent. I’m happy to report they weren’t and he got over the side effects which for him was stomatitis (mouth sores) and colitis. He could still participate in another trial later but right now his cancer is stable so luckily it’s not something he has to worry about right now. Good luck with whatever you decide.

[Pmann in reply to Avanat]

Thanks so much

[Pmann]

Sage words my friend

I must admit I am playing with house money

I was diagnosed with this disease in 2000

[Tall_Allen]

It is one of many BiTE (bi-specific T-cell engager) trials now going on. One end attaches to a surface protein on the cancer cell called B7-H3 and the other end attaches to a protein on T-cells.

Here's an early trial that used a different anti-B7-H3 medicine:

nature.com/articles/s41591-...

[gsun in reply to Tall_Allen]

That is for localized cancer.

[Pmann]

Thanks TA that is helpful

[pilot52]

I am currently in a Pfizer Trial . The paper work if you are not used to long consents are daunting. Count on your doctors opinion and not the consent. They watch you very close. If you do participate go into it with gusto and confidence. The trial team is there to administer the meds and not sure if yours are oral but comply to all instructions. If I can answer more direct questions pvt. msg . me.....The consent is an open contract which you can break at anytime. Good luck, Blue Skies and Always a Tailwind , Sky King and Penny ( woof)

[j-o-h-n]

Only thing more daunting is signing a marriage certificate..........

Good Luck, Good Health and Good Humor.

j-o-h-n

[Pmann in reply to j-o-h-n]

Understood, but you can leave the trial and not pay alimony

[addicted2cycling in reply to Pmann]

Opting out = no consequences for sure.

No alimony paid out if she has ALL THE MONEY. Been a happily kept man, now Eunuch for almost 51 years.

[ron_bucher]

I don't think there is such a thing as getting "blackballed" from trials.

[Stevecavill]

a phase 1 trial is usually of very little benefit to the participants. It’s looking for safety and tolerability, rather than efficacy. It’s usually offered to people who are failing standard therapies. Do you fit in that category.

I would only do a phase 1 trial as a last resort.

[Pmann in reply to Stevecavill]

Thanks for the comments.

I have been through most all SOC therapies. I can do chemo again.

I am on waitlist for several other trials.

This is the first one that came open.

[Stevecavill in reply to Pmann]

If you have been through all the other SOC options, then a phase 1 trial could be worth a try. Ideally phase 2 or 3 is better, because at this stage they don’t know what dose to use, and that’s what they test on you. But it’s probably better than nothing. And if the toxic effects are too high they will take you off the drug anyway.

Good luck.

[Brysonal]

I did a phase 1 vaccine trial as both my MOs said it wouldn’t negatively impact on my cancer. It was first in human but I was number 12 so not as brave as number 1

I wanted early access to the vaccine at maximum dose which I got by being the lady of the 1a cohort.

I wouldn’t have done one of the riskier trials as currently my cancer is undetectable/ NED so I relied on my Mos input that it was a low risk type

[inter100]

I have done a little research about TAK 280, and bi-specific T-cell engagers.Here's what I came across

pharmaceutical-technology.c...

not sure of the accuracy of the above, I'm always suspicious when asked to buy reports

nature.com/articles/s41591-...

takedaoncology.com/science/...

the one above gives some details of other trials the company is involved in.

cancer.gov/publications/dic...

Life changing decisions are hard to make. Research as much as you can and see if that "warm feeling" emerges

Tall_Allen has provided details of similar therapies, though not exactly the same , I am sure it will give insight when including them in your research🙏