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


Phase 2
18 Years
N/A
Not Enrolling
Both
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:

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.

Type of Study:

Interventional

Study Design:

Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Principal Investigator

MA Fischl

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 006

NCT ID:

NCT00000996

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

Name

Location

Bellevue Hosp / New York Univ Med CtrNew York, New York  10016
Mem Sloan - Kettering Cancer CtrNew York, New York  10021
Univ of Rochester Medical CenterRochester, New York  14642
UCLA CARE CtrLos Angeles, California  90095
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
George Washington Univ Med CtrWashington, District of Columbia  20037
Univ of Miami School of MedicineMiami, Florida  331361013
Tulane Univ School of MedicineNew Orleans, Louisiana  70112
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
SUNY / Erie County Med Ctr at BuffaloBuffalo, New York  14215
Ohio State Univ Hosp ClinicColumbus, Ohio  432101228
Charity Hosp / Tulane Univ Med SchoolNew Orleans, Louisiana  70112