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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000996
First received: November 2, 1999
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin.

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
 Drug: Doxorubicin hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 48
Study Completion Date: June 1990
Detailed Description:

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

Patients are stratified for non-therapy purposes into 2 groups; doxorubicin is given intravenously (IV) every week on an outpatient basis. Patients are monitored carefully, and weekly blood samples are taken to determine the effectiveness and safety of treatment. Patients are evaluated for toxicity after one dose of the drug and weekly thereafter. Patients are evaluated for response to the drug after 4 weeks and monthly thereafter.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Ongoing and/or maintenance therapy for opportunistic infection.
  • Medications for nausea, vomiting, and diarrhea resulting from drug.

Patients must have AIDS related Kaposi's sarcoma.

  • Patients may demonstrate positive blood cultures for Mycobacterium avium-complex or cytomegalovirus.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions will be excluded:

  • Patients with active opportunistic infection.
  • Patients with concurrent neoplasm other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
  • Patients with significant neurologic, cardiac, or liver disease.

Concurrent Medication:

Excluded:

  • Antiretroviral agents.
  • Immunomodulators.
  • Corticosteroids.
  • Experimental drugs.

The following patients will be excluded from the study:

  • Patients with lymphadenopathy alone and/or visceral disease alone secondary to Kaposi's sarcoma.

Prior Medication:

Excluded:

  • Cytotoxic chemotherapy.
  • Excluded within 30 days of study entry:
  • Antiretroviral agents.
  • Biologic modifiers.
  • Corticosteroids.

Prior Treatment:

Excluded:

  • Total body electron beam therapy.
  • Excluded within 30 days of study entry:
  • Radiation therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000996

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Louisiana
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
United States, New York
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States, 10021
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Univ of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Ohio
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: MA Fischl
  More Information

Publications:
Walker RE, et al. The safety, pharmacokinetics, and antiviral activity of N-acetylcysteine in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo8 (abstract no MoB 0022)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000996     History of Changes
Other Study ID Numbers: ACTG 006, 10982
Study First Received: November 2, 1999
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Doxorubicin
Drug Evaluation
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Slow Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013