Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Sarcoma, Kaposi

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 o...

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 t...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

June 1 1990

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT00000996

End Date

June 1 1990

Last Update

November 4 2021

Active Locations (12)

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Page 1 of 3 (12 locations)

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 D.C., District of Columbia, United States, 20037

4

Univ of Miami School of Medicine

Miami, Florida, United States, 331361013

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