PURPOSE: The aim of this phase I study was to determine the safety and @entity137 profile of @entity136 administered as an intravesical agent in @entity1 with @entity1606 ( @entity1606 ) of the bladder. @entity1 AND METHODS: @entity1 with superficial @entity150 refractory to intravesical bacillus Calmette-Gu  rin (BCG) therapy and refusing a cystectomy were considered eligible for the trial. @entity136 was given in the bladder for 1 hour twice weekly in 100 mL @entity2827 for a total of six treatments. After a 1-week break, a second course of six treatments over 3 weeks was given, followed by response assessment. Four dose levels were explored: 500 mg, 1,000 mg, 1,500 mg, and 2,000 mg. RESULTS: Eighteen @entity1 completed therapy: three at 500 mg, six at 1,000 mg, three at 1,500 mg, and six at 2,000 mg. No grade 3 or 4 @entity137 was observed at 500 mg. At 1,000 mg, three @entity1 developed @entity811 and one had a skin reaction resembling grade 3 @entity8566 . Three @entity1 at 1,500 mg had no grade 3 or 4 @entity137 . Of six @entity1 at 2,000 mg, one had grade 3 @entity882 and @entity1398 without @entity281 . Seven @entity1 had a complete response (negative cytology and posttreatment biopsy), and four @entity1 had a mixed response (negative bladder biopsy but positive cytology). CONCLUSION: @entity136 has substantial activity as an intravesical agent in BCG-refractory @entity1606 and warrants further investigation. Therapy given twice weekly was associated with minimal @entity1494 and tolerable myelosuppression. The recommended phase II dose for twice-weekly therapy is 2,000 mg.

Phase I trial of intravesical XXXX in bacillus Calmette-Gu  rin-refractory @entity1606 of the bladder.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity811 :: ('MESH:D006417', 'Disease') :: ['hematuria'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity882 :: ('MESH:D013921', 'Disease') :: ['thrombocytopenia'] @entity1494 :: ('MESH:D001745', 'Disease') :: ['bladder irritation'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infection'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity150 :: ('MESH:D001749', 'Disease') :: ['bladder cancer'] @entity1606 :: ('MESH:D002295', 'Disease') :: ['transitional-cell carcinoma', 'TCC'] @entity8566 :: ('MESH:D060831', 'Disease') :: ['hand-foot syndrome'] @entity2827 :: ('MESH:D012965', 'Chemical') :: ['sodium chloride'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['Gemcitabine', 'gemcitabine']
@entity136 :: (MESH:C056507,Chemical) :: ['gemcitabine']
