Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer
Brief 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.
Detailed description
OBJECTIVES: I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma. II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen. IV. Determine the overall survival of this patient population treated with this regimen. OUTLINE: Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Interventions
DRUGbryostatin 1
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed