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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000996

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma, Kaposi HIV Infections	Drug: Doxorubicin hydrochloride	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Jun 1, 1990

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	UCLA CARE Ctr	Los Angeles	California	United States	90095
2	San Francisco AIDS Clinic / San Francisco Gen Hosp	San Francisco	California	United States	941102859
3	George Washington Univ Med Ctr	Washington	District of Columbia	United States	20037
4	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
5	Charity Hosp / Tulane Univ Med School	New Orleans	Louisiana	United States	70112
6	Tulane Univ School of Medicine	New Orleans	Louisiana	United States	70112
7	Beth Israel Deaconess - West Campus	Boston	Massachusetts	United States	02215
8	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
9	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
10	Mem Sloan - Kettering Cancer Ctr	New York	New York	United States	10021
11	Univ of Rochester Medical Center	Rochester	New York	United States	14642
12	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	432101228