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

  • STATUS
    Recruiting
  • days left to enroll
    36
  • participants needed
    68
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 4 October 2022

Summary

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.

Details
Condition Non-Muscle Invasive Bladder Cancer (NMIBC)
Treatment Gemcitabine, Bacillus Calmette-Guérin (BCG)
Clinical Study IdentifierNCT04179162
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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)
Evidence of concurrent extravesical (i.e., urethra, ureter, or renal pelvis) urothelial cell carcinoma
or metastatic 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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