Brief Title: Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: evaluate the MTD (Phase I)

Primary Outcome 1 - Timeframe: 1 year

Primary Outcome 2 - Measure: proportion of patients who are disease free

Primary Outcome 2 - Timeframe: 6 months after the start of treatment

CONDITION

• Non-Muscle Invasive Bladder Cancer (NMIBC)

ELIGIBILITY

Inclusion Criteria:
Recurrent high-grade NMIBC Tis (with TaHG, or T1 also acceptable) within 24 months of the last treatment with BCG (with or without IFN)

- Pathologic confirmation of stage, grade, and urothelial histology by the Department of Pathology at MSK

- All visible papillary lesions macroscopically resected within 60 days of treatment initiation

- Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or ureteroscopy) within 12 months from the start of treatment

- Receipt of restaging transurethral resection (TUR) for any tumor with invasion into the lamina propria (HGT1) as part of standard care

- Age ≥18 years

- Karnofsky performance status ≥60%

- Informed consent
Exclusion Criteria:
Positive pregnancy test
Known contraindications to BCG
History of systemic hypersensitivity reaction or history of febrile systemic BCG reaction

- Febrile illness or persistent gross hematuria

- Active tuberculosis

- Immunosuppression due to congenital or acquired immune deficiency, concurrent immune suppressive disease, systemic cancer therapy, or chronic immunosuppressive therapy other than topical or inhaled corticosteroids

- History of or currently being treated for muscle-invasive (i.e., stage T2 or higher) or metastatic urothelial cell carcinoma

- Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma
BCG-unresponsive NMIBC as defined by the FDA:
HGT1 within 3 months after an induction BCG course (received ≥5 of 6 doses)

- Persistent or recurrent high-grade NMIBC (Tis, Ta, T1) within 6 months of ≥5 of 6 doses of induction BCG therapy and ≥2 of 3 doses of maintenance BCG therapy

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Eugene Pietzak, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Eugene Pietzak, MD

Phone: 646-422-4781, 1-646-422-4394

Email: pietzake@mskcc.org, dalbagng@mskcc.org

LOCATION