Status:
COMPLETED
A Phase I Study of Infusional Chemotherapy With the P-Glycoprotein Antagonist PSC 833
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Kidney Neoplasm
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagoni...
Detailed Description
The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagoni...
Eligibility Criteria
Biopsy proven metastatic cancer, for whom no better therapy exists. All patients are eligible. Enrollment of patients with kidney, breast, ovarian cancers, and lymphomas is encouraged.
A life expectancy of at least 16 weeks, and a performance status (Karnofsky scale) of 70% or greater. Patients without rapidly growing disease.
Any prior therapy except for previous bone marrow transplantation.
WBC greater than 3,000/mm3 and ACG greater than 1,000/mm3; platelets greater than 100,000/mm3.
Creatinine Clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; SGOT less than 70u/L; SGPT less than 80u/L.
A signed informed consent and geographic accessibility for the patient to return for follow up and treatment.
No history of brain metastases.
Not currently receiving treatment with the following agents or any other agent known to significantly interact with cyclosporine, and treatment cannot be discontinued, or changed to another therapeutically equivalent allowable drug: acetazolamide, barbiturates, corticosteroids, diltiazem, erythromycin, fluconazole, ketoconazole, nicardipine, phenothiazines, phenytoin, rifampin, sulfonamides, trimethoprim, verapamil, tamoxifen, progesterone, quinine, quinidine, or amiodarone.
No symptomatic peripheral neuropathy (grade 2 or greater arising from prior vinca alkaloid therapy).
No positive serology for HIV.
No ongoing pregnancy or unwillingness to practice adequate contraception.
Key Trial Info
Start Date :
September 1 1992
Trial Type :
INTERVENTIONAL
End Date :
June 1 2002
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00001302
Start Date
September 1 1992
End Date
June 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892