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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000996
  Purpose

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 Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Doxorubicin hydrochloride
Phase II

MedlinePlus related topics:   AIDS    Kaposi's Sarcoma    Soft Tissue Sarcoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Parallel Assignment
Official Title:   Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   48

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 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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000996

Locations
United States, California
San Francisco AIDS Clinic / San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
UCLA CARE Ctr    
      Los Angeles, California, United States, 90095
United States, District of Columbia
George Washington Univ Med Ctr    
      Washington, District of Columbia, United States, 20037
United States, Florida
Univ of Miami School of Medicine    
      Miami, Florida, United States, 331361013
United States, Louisiana
Charity Hosp / Tulane Univ Med School    
      New Orleans, Louisiana, United States, 70112
Tulane Univ School of Medicine    
      New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Beth Israel Deaconess - West Campus    
      Boston, Massachusetts, United States, 02215
United States, New York
Univ of Rochester Medical Center    
      Rochester, New York, United States, 14642
Mem Sloan - Kettering Cancer Ctr    
      New York, New York, United States, 10021
Bellevue Hosp / New York Univ Med Ctr    
      New York, New York, United States, 10016
SUNY / Erie County Med Ctr at Buffalo    
      Buffalo, New York, United States, 14215
United States, Ohio
Ohio State Univ Hosp Clinic    
      Columbus, Ohio, United States, 432101228

Sponsors and Collaborators

Investigators
Study Chair:     MA Fischl    
  More Information


Publications:
Walker RE, et al. The safety, pharmacokinetics, and antiviral activity of N-acetylcysteine in HIV-infected individuals. Int Conf AIDS. 1992 Jul 19-24;8(1):Mo8 (abstract no MoB 0022)
 
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.
 

Study ID Numbers:   ACTG 006
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000996
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Doxorubicin  
Drug Evaluation  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Doxorubicin
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Vascular Tissue
Lentivirus Infections
Antibiotics, Antineoplastic
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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