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

HIV Infections Clinical Trial

Official title:

Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000996
• Other study ID #: ACTG 006
• Secondary ID: 10982
• Status: Completed
• Phase: Phase 2
• Est. completion date: June 1990

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 1990
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Sarcoma
• Sarcoma, Kaposi

Intervention

Drug:
• Doxorubicin hydrochloride

Locations

Country	Name	City	State
United States	Beth Israel Deaconess - West Campus	Boston	Massachusetts
United States	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York
United States	Ohio State Univ Hosp Clinic	Columbus	Ohio
United States	UCLA CARE Ctr	Los Angeles	California
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Charity Hosp / Tulane Univ Med School	New Orleans	Louisiana
United States	Tulane Univ School of Medicine	New Orleans	Louisiana
United States	Bellevue Hosp / New York Univ Med Ctr	New York	New York
United States	Mem Sloan - Kettering Cancer Ctr	New York	New York
United States	Univ of Rochester Medical Center	Rochester	New York
United States	San Francisco AIDS Clinic / San Francisco Gen Hosp	San Francisco	California
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fischl MA, Krown SE, O'Boyle KP, Mitsuyasu R, Miles S, Wernz JC, Volberding PA, Kahn J, Groopman JE, Feinberg J, et al. Weekly doxorubicin in the treatment of patients with AIDS-related Kaposi's sarcoma. AIDS Clinical Trials Group. J Acquir Immune Defic Syndr (1988). 1993 Mar;6(3):259-64. — View Citation

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)