To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

Condition	Treatment or Intervention	Phase
Sarcoma, Kaposi HIV Infections	Drug: Doxorubicin hydrochloride (liposomal)  Drug: Bleomycin sulfate  Drug: Vincristine sulfate  Drug: Doxorubicin hydrochloride	Phase III

Further Study Details: 

Expected Total Enrollment:  225

Patients are randomized to receive either DOX-SL or the ABV combination. Infusions are given on day 1 and every 2 weeks for a total of six cycles. Kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. Patients must agree to have one or more representative KS lesions biopsied.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

Concurrent Medication: Allowed:

• Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
• Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
• Foscarnet for new episodes of cytomegalovirus infection.
• Colony-stimulating factors and erythropoietin. Patients must have:
• Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following: - At least 25 mucocutaneous lesions. - Ten or more new lesions in the prior month. - Documented visceral disease with at least two accessible cutaneous lesions. - Two accessible cutaneous lesions with edema.
• Documented anti-HIV antibody.
• No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
• Life expectancy > 4 months. NOTE:
• Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone.

Exclusion Criteria

Co-existing Condition: Patients with the following symptoms or conditions are excluded:

• Clinically significant cardiac, hepatic, or renal disease.
• Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
• Inability to comply with the study. Concurrent Medication: Excluded:
• Other cytotoxic chemotherapy.
• Ganciclovir. Patients with the following prior conditions are excluded:
• Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
• History of idiosyncratic or allergic reaction to bleomycin or vincristine. Prior Medication: Excluded:
• Prior anthracycline therapy.
• Cytotoxic chemotherapy or interferon treatment within the past 4 weeks. Prior Treatment: Excluded:
• Radiation or electron beam therapy within the past 3 weeks.

California
      UCSF - San Francisco Gen Hosp, San Francisco,  California,  94110,  United States
      Kaiser Permanente Med Ctr, San Francisco,  California,  94115,  United States
      Dr Becky Miller, Los Angeles,  California,  90048,  United States
      Pacific Oaks Med Group, Beverly Hills,  California,  90211,  United States
      Hematology - Oncology Med Group of San Fernando Valley, Encino,  California,  91436,  United States
      Apogee Med Group, San Diego,  California,  92103,  United States
      San Francisco Veterans Administration Med Ctr, San Francisco,  California,  94121,  United States
      UCSF, San Francisco,  California,  94117,  United States
      UCSF, San Francisco,  California,  941430324,  United States
      Pacific Oaks Med Group, Sherman Oaks,  California,  91403,  United States
      East Bay AIDS Ctr, Berkeley,  California,  94705,  United States
District of Columbia
      Dr Mahmoud Mustafa, Washington,  District of Columbia,  20037,  United States
Florida
      Univ of Miami School of Medicine, Miami,  Florida,  33136,  United States
      H Lee Moffit Cancer Ctr and Research Institute, Tampa,  Florida,  33612,  United States
Georgia
      American Med Research Institute, Atlanta,  Georgia,  30329,  United States
      Infectious Disease Rsch Consortium of GA / SE Clin Resources, Atlanta,  Georgia,  30345,  United States
Illinois
      Rush Presbyterian Med College, Chicago,  Illinois,  60612,  United States
      Illinois Masonic Med Ctr / The Cancer Ctr, Chicago,  Illinois,  60657,  United States
      Northwestern Med Faculty Foundation, Chicago,  Illinois,  60611,  United States
Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States
Missouri
      Washington Univ, St. Louis,  Missouri,  63108,  United States
New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263,  United States
      New York Univ Med Ctr, New York,  New York,  10016,  United States
      Saint Luke's - Roosevelt Hosp Ctr, New York,  New York,  10023,  United States
      Saint Vincent's Hosp and Med Ctr, New York,  New York,  10011,  United States
Pennsylvania
      Graduate Hosp / Tuttleman Cancer Ctr, Philadelphia,  Pennsylvania,  19146,  United States
Texas
      Comprehensive Care Ctr, Dallas,  Texas,  75235,  United States
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

Study ID Numbers:  134A; LTI-30-10
Record last reviewed:  January 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002318
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08