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

Phase 2
18 Years
Not Enrolling
Sarcoma, Kaposi, HIV Infections

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Trial Information

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

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.

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:


- 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

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:


- 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:


- Cytotoxic chemotherapy.

- Excluded within 30 days of study entry:

- Antiretroviral agents.

- Biologic modifiers.

- Corticosteroids.

Prior Treatment:


- Total body electron beam therapy.

- Excluded within 30 days of study entry:

- Radiation therapy.

Type of Study:


Study Design:

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

MA Fischl

Investigator Role:

Study Chair


United States: Federal Government

Study ID:

ACTG 006



Start Date:

Completion Date:

June 1990

Related Keywords:

  • Sarcoma, Kaposi
  • HIV Infections
  • Doxorubicin
  • Drug Evaluation
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Sarcoma, Kaposi
  • Sarcoma



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Univ of Rochester Medical Center Rochester, New York  14642
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George Washington Univ Med Ctr Washington, District of Columbia  20037
Univ of Miami School of Medicine Miami, Florida  331361013
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Beth Israel Deaconess - West Campus Boston, Massachusetts  02215
SUNY / Erie County Med Ctr at Buffalo Buffalo, New York  14215
Ohio State Univ Hosp Clinic Columbus, Ohio  432101228
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