Phase I/II Trial of Bacillus Calmette-Guérin (BCG) and Intravesical Gemcitabine for Patients With BCG-Relapsing High-Grade Non-Muscle Invasive Bladder Cancer

Condition: Non-Muscle Invasive Bladder Cancer (NMIBC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04179162

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 1/Phase 2


  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

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