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Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers



Liposomal Doxorubicin and PSC 833 in Treating Patients With AIDS-Related Kaposi's Sarcoma or Other Advanced Cancers

For Condition: epidemic Kaposi's sarcoma,recurrent Kaposi's sarcoma,unspecified adult solid tumor, protocol specific
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Washington University Barnard Cancer Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven Kaposi's sarcoma with 10 or more mucocutaneous lesions or a visceral lesion with at least 2 assessable cutaneous lesions OR Histologically confirmed advanced malignancy that is refractory to standard treatment or for which no standard therapy exists --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior interferon - Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy; Prior doxorubicin HCl liposome allowed; No other concurrent cytotoxic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy or external beam therapy; No concurrent palliative radiotherapy - Surgery: Not specified - Other: No concurrent medications known to interact with cyclosporine --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: More than 4 months - Hematopoietic: Neutrophil count at least 1,000/mm3; Platelet count at least 75,000/mm3; Hemoglobin at least 8 g/dL - Hepatic: Bilirubin less than 1.5 times normal; SGOT no greater than 2 times normal - Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min - Cardiovascular: No clinically significant congestive heart failure - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No active opportunistic infections requiring antibiotic treatment; No moderate to severe sensory and motor peripheral neuropathy; No other prior or concurrent malignancy except carcinoma in situ of the cervix or nonmelanoma skin cancer; No hypersensitivity to doxorubicin HCl liposome or cyclosporine
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PaulaFracasso,  Study Chair,  Washington University Barnard Cancer Center

Washington University Barnard Cancer Center
St. Louis,  Missouri,  63110
United States
 


Additional Information:
Study ID Numbers:  CDR0000066062;  WU-106,NCI-T97-0073
Study Start Date: February 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003207

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3. COL-3 in Treating Patients With HIV-Related Kaposi's Sarcoma

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