Study on Adding Gemcitabine to Standard BCG Treatment for Recurrent Non-Muscle Invasive Bladder Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT07000084
This clinical trial is testing whether adding the chemotherapy drug gemcitabine to the usual BCG treatment can better control bladder cancer that has returned after previous BCG therapy.
Patient Parameters
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Program Overview
This study is exploring if combining gemcitabine, a chemotherapy drug, with the standard BCG treatment can more effectively kill cancer cells in patients with non-muscle invasive bladder cancer that has come back after initial improvement. BCG is a solution placed in the bladder to stimulate the immune system to attack cancer cells. Gemcitabine works by blocking cancer cells from making DNA, which may help kill them. The trial aims to see if this combination can reduce the recurrence of bladder cancer more effectively than BCG alone.
Description
The main goal of this study is to compare how well patients do without high-grade cancer returning when treated with gemcitabine and BCG versus BCG alone. Other goals include comparing how many patients remain cancer-free after treatment, how long it takes for cancer to return, and the safety of the treatments. Patients will be randomly assigned to one of two groups: one receiving BCG alone and the other receiving both gemcitabine and BCG. Both groups will undergo regular check-ups, including bladder biopsies and scans, to monitor their health and the treatment's effectiveness. After completing the treatment, patients will have follow-up visits every few months for up to five years to track their progress.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of high-grade non-muscle invasive bladder cancer (NMIBC) within 120 days before joining the study.
- Cannot have any neuroendocrine carcinoma components in their cancer.
- All visible cancer must be removed by a procedure called TURBT within 90 days before joining the study.
- Must have had previous BCG treatment for NMIBC, with cancer returning within 24 months of the last BCG treatment.
- Cannot have BCG-unresponsive NMIBC, which means cancer returned too soon after adequate BCG treatment.
- Can have had more than one BCG treatment course, as long as they do not currently meet the criteria for BCG-unresponsive disease.
- Can have had previous intravesical chemotherapy or other treatments for NMIBC.
- Must not have a history of intolerance to BCG or other bladder treatments.
- Must not have muscle-invasive bladder cancer or cancer that has spread beyond the bladder.
- Must be 18 years or older.
- Must not be pregnant or breastfeeding, and women of childbearing potential must have a negative pregnancy test before joining the study.
- HIV-positive patients can join if they are on effective treatment with an undetectable viral load.
- Patients with other cancers can join if those cancers do not interfere with this study's treatment or assessments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | 92868 | Orange | California |
| University of Florida Health Science Center - Gainesville | 32610 | Gainesville | Florida |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| Kootenai Health - Coeur d'Alene | 83814 | Coeur d'Alene | Idaho |
| Kootenai Clinic Cancer Services - Post Falls | 83854 | Post Falls | Idaho |
| Kootenai Clinic Cancer Services - Sandpoint | 83864 | Sandpoint | Idaho |
| Northwestern University | 60611 | Chicago | Illinois |
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