Bacillus Calmette-Guérin (BCG) and Gemcitabine in People With High-Grade Non-Muscle Invasive Bladder Cancer That Came Back After BCG Treatment
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Non-Muscle Invasive Bladder Cancer (NMIBC)
In brief
This study will test the safety of BCG and gemcitabine in people who have BCG-relapsing Non-Muscle Invasive Bladder Cancer (NMIBC). The researchers will test increasing doses of gemcitabine to find the highest dose that causes few or mild side effects when combined with BCG. The study will also look at whether this combination of drugs is effective in treating BCG-relapsing NMIBC.
Key facts
- Study ID
- NCT04179162
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 54
- Starts
- 2019-11-22
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Recurrent for persistent high-grade NMIBC Ta/T1/Tis (Ta/T1 with CIS is preferred, but not required) within 24 months of the last treatment with BCG (with or without IFN)
- o Up to 26 months from the last BCG treatment is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence of recurrent disease (by positive cytology, imaging, or office cystoscopy) within 24 months of last BCG transurethral resection of bladder tumor (TURBT)
- 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
You may not qualify if…
- 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
Where it is running
- Hartford Healthcare (Data Collection) — Hartford, Connecticut, United States
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States
Full record on ClinicalTrials.gov
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