Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

Date de début de l'étude : 1 juin 1999

DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell carcinoma Bidimensionally measurable disease Clear evidence of progression if only site of measurable disease is within previous radiation port Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 3 months WBC at least 3,000/mm3 Platelet count at least 100,00/mm3 Bilirubin no greater than 1.5 mg/dL Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study No active bacterial or viral infection No serious underlying medical condition that would interfere with compliance No other malignancy within the past 5 years except basal cell carcinoma of the skin No dementia or altered mental status that would prevent informed consent PRIOR CONCURRENT THERAPY: No more than 1 prior therapy with biologic response modifiers No prior chemotherapy for advanced disease No other concurrent chemotherapy No concurrent steriods (except topical use) At least 4 weeks since prior radiotherapy No concurrent radiotherapy At least 4 weeks since major surgery (including nephrectomy) No other concurrent experimental agents