A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002319
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
Sarcoma, Kaposi HIV Infections Drug: Doxorubicin hydrochloride (liposomal) Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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).


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002319

  Hide Study Locations
United States, California
East Bay AIDS Ctr
Berkeley, California, United States, 94705
Pacific Oaks Med Group
Beverly Hills, California, United States, 90211
Hematology - Oncology Med Group of San Fernando Valley
Encino, California, United States, 91436
Dr Becky Miller
Los Angeles, California, United States, 90048
Apogee Med Group
San Diego, California, United States, 92103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Kaiser Permanente Med Ctr
San Francisco, California, United States, 94115
San Francisco, California, United States, 94117
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
San Francisco, California, United States, 941430324
Pacific Oaks Med Group
Sherman Oaks, California, United States, 91403
United States, District of Columbia
Dr Mahmoud Mustafa
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 33136
H Lee Moffit Cancer Ctr and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
American Med Research Institute
Atlanta, Georgia, United States, 30329
Infectious Disease Rsch Consortium of GA / SE Clin Resources
Atlanta, Georgia, United States, 30345
United States, Illinois
Northwestern Med Faculty Foundation
Chicago, Illinois, United States, 60611
Rush Presbyterian Med College
Chicago, Illinois, United States, 60612
Illinois Masonic Med Ctr / The Cancer Ctr
Chicago, Illinois, United States, 60657
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, Missouri
Washington Univ
St. Louis, Missouri, United States, 63108
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
New York Univ Med Ctr
New York, New York, United States, 10016
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10023
Mount Sinai Med Ctr
New York, New York, United States, 10029
United States, Pennsylvania
Graduate Hosp / Tuttleman Cancer Ctr
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Comprehensive Care Ctr
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77030
Houston Immunological Institute
Houston, Texas, United States, 77054
Twelve Oaks Hosp
Houston, Texas, United States, 77074
United States, Washington
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Sequus Pharmaceuticals

Jablonowski H, Szelenyi H, Armbrecht C, Mauss S, Niederau C, Strohmeyer G. Liposomal doxorubicin--a new formulation for the treatment of Kaposi's sarcoma: a study on safety and efficacy in AIDS patients. Int Conf AIDS. 1993 Jun 6-11;9(1):397 (abstract no PO-B12-1573) Identifier: NCT00002319     History of Changes
Other Study ID Numbers: 134C
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 1996

Keywords provided by NIH AIDS Clinical Trials Information Service:
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Drug Carriers

Additional relevant MeSH terms:
HIV Infections
Sarcoma, Kaposi
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Vascular Tissue
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action