Clinical Trial Information
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- High grade Ta, T1 or CIS urothelial carcinoma and Recurrent disease after completing therapy with at least induction BCG
(≥5 doses) and the first round of maintenance or second induction course (≥2 doses).
- Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy.
- All visible tumor must be completely resected within 60 days of before registration (residual pure CIS is permitted).
- All patients must have histologically confirmed urothelial cancer of the bladder within 60 days after starting BCG.
- All patients must have had a cystoscopy without papillary tumor and negative urinary cytology within 21 days before
registration. (Positive cytology is allowed in patients with pure CIS).
- Mixed variant histology (adenocarcinoma, squamous cell carcinoma)
- Patients with T1 tumors must undergo a re-staging TURBT within 60 days before registration.
- No evidence of metastasis documented with CT or MRI abd/pelvis within 90 days prior to registration.
- No history of urothelial carcinoma in the ureters or prostatic urethra within 24 months of registration.
- No prior or concurrent systemic chemotherapy or immunotherapy. (Prior intravesical chemo and interferon is allowed. Single dose chemotherapy post TURBT is allowed.)
- No prior bladder radiation.
- Age ≥ 18 years.
- ECOG Performance Status: 0-2.
- No known additional malignancy that has had progression or has required active treatment in the last three years.
- History of prostate cancer that was treated with definitive intent is allowed.
- No active autoimmune disease requiring systemic treatment within 24 months prior to registration.