To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who previously had good responses to DOX-SL in controlled studies of limited duration, or those with KS who discontinued treatment with another Kaposi's sarcoma therapy because of inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's sarcoma patients for whom DOX-SL therapy is indicated.

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

Further Study Details: 

Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.

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 provided these doses have been stable for at least 1 month.
• Maintenance therapy for tuberculosis, fungal, and herpes infections.
• Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
• Foscarnet or ganciclovir for CMV infection.
• Colony stimulating factors and erythropoietin. Patients must have:
• Moderate to severe AIDS-related Kaposi's sarcoma.
• Documented anti-HIV antibody.
• No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). NOTE:
• Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies.

Exclusion Criteria

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

• Clinically significant cardiac disease.
• Confusion or disorientation. Concurrent Medication: Excluded:
• Other cytotoxic cancer chemotherapy. Patients with the following prior conditions are excluded:
• Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function.
• History of idiosyncratic or allergic reaction to anthracyclines.
• History of major psychiatric illness. Prior Medication: Excluded within the past 4 weeks:
• Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol).
• Interferon treatment. Prior Treatment: Excluded within the past 3 weeks:
• Radiation or electron beam therapy.

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
      Mount Sinai Med Ctr, New York,  New York,  10029,  United States
      Mem Sloan - Kettering Cancer Ctr, New York,  New York,  10021,  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
      Twelve Oaks Hosp, Houston,  Texas,  77074,  United States
      Houston Immunological Institute, Houston,  Texas,  77054,  United States
Washington
      Virginia Mason Research Center / Clinical Trial Unit, Seattle,  Washington,  98101,  United States

Study ID Numbers:  134C; LTI-30-12
Record last reviewed:  January 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002319
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08