Status:
COMPLETED
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Kidney Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To ensure the saf...
Detailed Description
The Phase I clinical trial of the combination of 120-hour continuous intravenous infusion of vinblastine with oral PSC 833 has shown activity in patients with advanced malignancies, particularly renal...
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically proven renal cancer with clear cell component:
Measurable or evaluable disease;
No brain metastases;
No grade 2 or greater peripheral neuropathy or neurologic toxicity symptoms.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy: No prior or concurrent hypersensitivity to PSC 833 or cyclosporine A.
Endocrine Therapy: Not specified.
Radiotherapy: No prior radiation therapy within 4 weeks of study.
Surgery: No major surgery within 4 weeks of study.
Other: No concurrent treatments that interfere with cyclosporine blood concentrations.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance Status: ECOG 0-2.
Life Expectancy: At least 16 weeks.
Hematopoietic:
ANC greater than or equal to 1500/mm(3);
Platelet count greater than or equal to 100,000/mm(3).
Hepatic:
Bilirubin no greater than 1.5 x normal;
AST no greater than 2.5 x normal.
Renal:
Creatinine no greater than 2.0 mg/dL OR;
Creatinine clearance greater than or equal to 50 mL/min.
Cardiovascular:
No concurrent angina or myocardial infarction that has not been appropriately treated.
Other:
Not pregnant or nursing.
Effective contraceptive required of all fertile patients.
Patients with a history of curatively treated basal cell or squamous cell carcinoma are eligible.
No HIV seropositivity.
No chronic hepatitis or cirrhosis.
Patients with concurrent reversible conditions such as diabetes, hypercalcemia, hyperuricemia, hyperviscosity, infection, renal disease, or spinal cord compression are eligible with appropriate therapy.
Patients must give written informed consent.
Key Trial Info
Start Date :
February 1 1997
Trial Type :
INTERVENTIONAL
End Date :
January 1 2001
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00001570
Start Date
February 1 1997
End Date
January 1 2001
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892