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

Inclusion Criteria

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