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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with a chemotherapy drug may reduce resistance to the drug and allow more tumor cells to be killed.
PURPOSE: Phase I trial to study the effectiveness of liposomal doxorubicin and PSC 833 in treating patients who have AIDS-related Kaposi's sarcoma or other advanced cancers.
OBJECTIVES: I. Evaluate the safety profile and tolerability of doxorubicin HCl liposome (Doxil) and PSC 833 in patients with AIDS-related Kaposi's sarcoma and other advanced malignancies. II. Determine the maximum tolerated dose of Doxil when administered with PSC 833 in this patient population. III. Determine the dose-limiting toxicity of Doxil when administered with PSC 833 in this patient population. IV. Determine the effects of PSC 833 on Doxil pharmacokinetics.
OUTLINE: This is a dose-escalation study of doxorubicin HCl liposome (Doxil). Patients receive Doxil IV over 1 hour on day 1 of each course. During the second and subsequent courses, patients also receive a loading dose of PSC 833 IV over 2 hours and a maintenance dose of PSC 833 IV over 72 hours beginning 15 minutes after completion of Doxil infusion. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. The first seven cohorts of patients receive standard-dose Doxil. The eighth and ninth cohorts of 3-6 patients each receive escalating doses of Doxil until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18 months.
Primary Purpose: Treatment
pegylated liposomal doxorubicin hydrochloride, valspodar
Washington University Barnard Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:36:05-0400
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