- "TAR-200 is a miniature, pretzel-shaped drug-device duo containing a chemotherapy drug, gemcitabine, which is inserted into the bladder through a catheter. Once inside the bladder, the TAR-200 slowly and consistently releases the gemcitabine into the organ for three weeks per treatment cycle."
- Phase 2 Clinical Trial
- 85 patients with high-risk non-muscle-invasive bladder cancer
- "treated patients with TAR-200 every three weeks for six months, and then four times a year for the next two years"
- 70/85 patients—the cancer disappeared and still gone 1yr later in almost 50% patients
- FDA granted TAR-200 a New Drug Application Priority Review
Do cancers have a tendency to come back with better drug resistance if it's not fully eliminated? at least a resistance to the drug that got rid of it the previous time?
My father currently suffers from bladder cancer, he's currently in palliative care, he's in Ukraine. If there are any medical professionals here, could someone provide an advice - is there any chance to get him access to TAR-200?
You may want to look at this study. Its preapproval expanded access. There is an email and phone numbers for the company which is running the study. Usually the further along the drug trial is they more the loosen the criteria. Wouldn't hurt the ask if its suitable for your father.
FWIW I can recommend Bundeswehrkrankenhaus Berlin, very good urology clinic there. Not sure if there's any chance for you since it's another country, but they're rather accepting and I'd say once there's patient with a life-threatening condition in their emergency they'd rather put them through the CT and into their surgical room rather than waste time. I feel a little shocked that your father is under palliative.
No, the trial is closed to new participants. Check the company website to see if they are having international trials or are open to compassionate use.
Very sorry for your loss. An uncle had bladder cancer about 15 years ago, and while he survived, it began a very steep decline that led to his passing in 2022.
Some important things not mentioned in this press release (not to detract from the idea of new treatment approaches of any sort):
- All patients had their tumors surgically removed before they were started on treatment. Thus the trial wasn't testing cure so much as delay of recurrence.
- These were very superficial tumors, meaning they were growing on the very surface of the inner bladder, just like skin tags. These aren't the ones that kill people. Patients with superficial bladder cancer who don't respond to BCG can be treated for quite a while just by having the tumors surgically removed whenever they recur (using a minimally-invasive procedure known as a transurethral resection of bladder tumors, TURBT).
- Fun with words: the press release called this a clinical trial, but it's not -- it has no controls, no real statistics, no randomization, none of the things that make up the usual standard in medicine. The authors of the paper call it a "study", which is basically a research experiment. They don't use the word "trial" at all in the paper.
Having said all that, I still look forward to seeing a proper trial.
By the tenor of your response, I assume you understood what I meant in this very-non-medical of forums, which means you understood why the paper's authors themselves chose not to call their study a trial (even though they registered it as a "clinical trial", as is necessary for any clinical study in humans involving a treatment intervention). Which leaves me wondering about the purpose of your response.
I'm perturbed by PR-driving rhetoric in the medical world because of what this causes, e.g. another commenter asking about a family member and if this could be helpful. Seeing what isn't directly visible in the PR is important in this case.
My father had bladder cancer, which was caught relatively early as the cancer had not yet spread beyond the bladder wall.
The doctor performed a rather uncomfortable surgery (the pathway for a man is not pleasant) and then injected the TB virus into his bladder, which is apparently an effective treatment for this type of cancer.
It's been 20 years now, no recurrence. Think he was treated at Dana Farber in Boston.
Having gone through what was likely a life saving treatment he has become, ironically, anti-western medicine -- don't blame him, having a surgical implement shoved up main street doesn't sound like a walk in the park :)
This is relatively common with experimental therapies in trials, and thus shouldn't be interpreted as the final say on its usage.
Part of the reason why is that it's difficult to convince patients or providers to reach for the experimental treatment in trial before the current standard of care. Many first-line treatments began as second/third-line or salvage treatments before experiencing line promotion or (if surgery is involved) neoadjuvant promotion. Keytruda is a good example of this progression in action.
Only those patients were admitted to the trial, so the effectiveness of the treatment on later-stage muscle-invasive disease is unknown. That it's scoped to patients who are BCG-unresponsive ("previously resisted treatment") makes the breakthrough more significant, not less.
Readit News
- "TAR-200 is a miniature, pretzel-shaped drug-device duo containing a chemotherapy drug, gemcitabine, which is inserted into the bladder through a catheter. Once inside the bladder, the TAR-200 slowly and consistently releases the gemcitabine into the organ for three weeks per treatment cycle."
- Phase 2 Clinical Trial
- 85 patients with high-risk non-muscle-invasive bladder cancer
- "treated patients with TAR-200 every three weeks for six months, and then four times a year for the next two years"
- 70/85 patients—the cancer disappeared and still gone 1yr later in almost 50% patients
- FDA granted TAR-200 a New Drug Application Priority Review
- Johnson & Johnson manufactures TAR-200
This is an unusually effective treatment with remarkably smaller side effects.
If it is this good, it will probably start getting used more broadly.
https://euclinicaltrials.eu/ctis-public/view/2023-507685-10-...
To be honest, chances are slim to none. But worth a try.
https://clinicaltrials.gov/study/NCT06877676?intr=TAR-200&ra...
2.See if your father qualifies for any
3. Enroll
4. Get B2 visa. All medical treatment is usually covered once you are accepted into the program.
good luck!
https://my.clevelandclinic.org/health/treatments/17908-bacil...
Deleted Comment
- All patients had their tumors surgically removed before they were started on treatment. Thus the trial wasn't testing cure so much as delay of recurrence.
- These were very superficial tumors, meaning they were growing on the very surface of the inner bladder, just like skin tags. These aren't the ones that kill people. Patients with superficial bladder cancer who don't respond to BCG can be treated for quite a while just by having the tumors surgically removed whenever they recur (using a minimally-invasive procedure known as a transurethral resection of bladder tumors, TURBT).
- Fun with words: the press release called this a clinical trial, but it's not -- it has no controls, no real statistics, no randomization, none of the things that make up the usual standard in medicine. The authors of the paper call it a "study", which is basically a research experiment. They don't use the word "trial" at all in the paper.
Having said all that, I still look forward to seeing a proper trial.
Edit: wordsmithing.
Yes, it is.
Any intervention in humans that is meant to create generalizable information regarding a treatment intervention is a clinical trial.
The quality of the information is not as strong as a double-blind, placebo controlled, RCT, but it is still accurate to call it a clinical trial.
The doctor performed a rather uncomfortable surgery (the pathway for a man is not pleasant) and then injected the TB virus into his bladder, which is apparently an effective treatment for this type of cancer.
It's been 20 years now, no recurrence. Think he was treated at Dana Farber in Boston.
Having gone through what was likely a life saving treatment he has become, ironically, anti-western medicine -- don't blame him, having a surgical implement shoved up main street doesn't sound like a walk in the park :)
> ...for individuals with high-risk non-muscle-invasive bladder cancer whose cancer had previously resisted treatment
Part of the reason why is that it's difficult to convince patients or providers to reach for the experimental treatment in trial before the current standard of care. Many first-line treatments began as second/third-line or salvage treatments before experiencing line promotion or (if surgery is involved) neoadjuvant promotion. Keytruda is a good example of this progression in action.
It's 82% of those whose bladder cancer is fortunately not invading the muscle, and after failing current standard treatments.
(1) For this trial, patients with MIBC (as opposed to NMIBC) weren't in the cohort, so we don't know what the results will be with MIBC.
(2) "After failing current standard treatments" makes the result more impressive, not less.
> https://www.sciencedirect.com/science/article/pii/S107814392...