GAIN-BCG: Gemcitabine Alternating With INtravesical BCG Randomized Against BCG Alone for Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer
Alliance for Clinical Trials in Oncology
Summary
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.
Description
PRIMARY OBJECTIVE: I. To compare high-grade recurrence-free-survival between treated with gemcitabine with BCG (GemBCG) compared to those treated with BCG alone. SECONDARY OBJECTIVES: I. To compare the proportion of patients who remain high grade cancer free on initial post-treatment cystoscopic biopsies/transurethral resection of bladder tumor (TURBT) (week 13/month 3) between those treated with GemBCG compared to those treated with BCG alone. II. To compare the 6-month (Week 25) complete response rate and the complete response durability between patients treated with GemBCG compared to t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documentation of Disease: Histologic confirmation of urothelial carcinoma that is high grade Ta, high grade T1, or Tis (Tis/carcinoma in situ \[CIS\] only disease) within 120 days prior to randomization * Any component of neuroendocrine carcinoma (i.e., small cell or large cell) is not allowed. Other histologic subtypes/variant histologies are allowed so long as there is a predominantly urothelial component. \* Note: Pure squamous cell carcinoma or pure adenocarcinoma without a urothelial component are not allowed * All visible papillary lesions must be macroscopicall…
Interventions
- BiologicalBCG Solution
Given intravesically
- ProcedureBiopsy of Bladder
Undergo bladder biopsy
- ProcedureCystoscopy
Undergo cystoscopy
- ProcedureComputed Tomography
Undergo CT Scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureTransurethral Resection of Bladder Tumor
Locations (56)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California
- Sibley Memorial HospitalWashington D.C., District of Columbia