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A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
This study has been completed.
Study NCT00000996   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00000996 on ClinicalTrials.gov Archive Site
 
 
 
A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma

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.

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.

Phase II
Interventional
Treatment, Parallel Assignment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Doxorubicin hydrochloride
 
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. 1993 Mar;6(3):259-64.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
48
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000996
 
ACTG 006
National Institute of Allergy and Infectious Diseases (NIAID)
 
Study Chair: MA Fischl
National Institute of Allergy and Infectious Diseases (NIAID)
July 1988

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP