Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bryostatin 1

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