Drug Screening Using IMD for Bladder Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This research study involves implanting up to 4 microdevices, each small enough to fit inside the tip of a needle, into a tumor. These devices will release microdoses (many thousands of times less than a treatment dose) of different cancer drugs into the tumor. After approximately 72 hours, the devices and small regions of surrounding tissue will be removed and studied. There will be a follow-up visit within 42 days of device removal to assess for potential safety issues or side effects.

Eligibility Criteria

This trial is for adults with localized bladder cancer, ready for cystectomy, and have a tumor at least 1cm big. They must understand the study and consent to it, be medically stable for procedures, meet certain blood test criteria, and agree to genetic testing. Those with uncontrolled illnesses or bleeding disorders that increase surgery risks can't join.

Inclusion Criteria

Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, PT (INR) 1.5 and PTT<1.5x control

Patients must be agree to remain abstinent or use contraceptive measures for the duration of the study period

I am 18 years old or older.

+7 more

Exclusion Criteria

I do not have a bleeding or clotting disorder that makes surgery risky.

I do not have any severe illnesses that would make surgery or biopsy unsafe.

Participant Groups

The study tests microdoses of various cancer drugs delivered directly into the tumor via implantable microdevices. After about three days, devices are removed along with some tissue for analysis. The aim is to see how different drugs affect the tumor in a very localized way without affecting other body parts.

1Treatment groups

Experimental Treatment

Group I: DRUG SCREENING USING IMD IN BLADDER CANCERExperimental Treatment21 Interventions

Study participants placed in arm 1 will be implanted with the microdevice.

Avelumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Bavencio for: