Testing the Addition of an Anti-Cancer Drug, Gemcitabine, to Usual Treatment (BCG Alone) in People Whose Non-Muscle Invasive Bladder Cancer (NMIBC) Came Back After Prior BCG Therapy (NCT07000084)
GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer
🩺 Plain-English Summary (8th-Grade Level)
This phase III trial compares the effect of adding gemcitabine to intravesical Bacillus Calmette Guerin (BCG) versus intravesical BCG alone in patients with non-muscle invasive bladder cancer that has come back after a period of improvement (recurrent). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Intravesical BCG is a solution containing the live BCG bacteria that is placed in the bladder via a catheter (intravesical). When the solution comes into direct contact with the bladder wall, it stimulates the body's immune system which kills tumor cells. Giving gemcitabine with intravesical BCG may kill more tumor cells in patients with recurrent non-muscle invasive bladder cancer.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (58 Sites)
Showing the first 25 of 58 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Fairbanks Memorial Hospital — Fairbanks, Alaska
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Sibley Memorial Hospital — Washington D.C., District of Columbia
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida
- Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho
- Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho
- Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho
- Northwestern University — Chicago, Illinois
- University of Illinois — Chicago, Illinois
- Loyola University Medical Center — Maywood, Illinois
- Marjorie Weinberg Cancer Center at Loyola-Gottlieb — Melrose Park, Illinois
- IU Health West Hospital — Avon, Indiana
- IU Health North Hospital — Carmel, Indiana
- Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana
- IU Health Methodist Hospital — Indianapolis, Indiana
- Mary Bird Perkins Cancer Center - Metairie — Metairie, Louisiana
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
- FMH James M Stockman Cancer Institute — Frederick, Maryland
- Brigham and Women's Hospital — Boston, Massachusetts
- Lahey Clinic — Burlington, Massachusetts
📞 Contact the Study Coordinator
Phone: (773) 702-9171
Email: guprotocols@alliancenctn.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Recurrent Non-Muscle Invasive Bladder Carcinoma
Explore by condition: All Recurrent Non-Muscle Invasive Bladder Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.