search
Back to results

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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Doxorubicin hydrochloride
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Doxorubicin, Drug Evaluation, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA CARE Ctr
  • San Francisco AIDS Clinic / San Francisco Gen Hosp
  • George Washington Univ Med Ctr
  • Univ of Miami School of Medicine
  • Charity Hosp / Tulane Univ Med School
  • Tulane Univ School of Medicine
  • Beth Israel Deaconess - West Campus
  • SUNY / Erie County Med Ctr at Buffalo
  • Bellevue Hosp / New York Univ Med Ctr
  • Mem Sloan - Kettering Cancer Ctr
  • Univ of Rochester Medical Center
  • Ohio State Univ Hosp Clinic

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000996
Brief Title
A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma
Official Title
Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1990 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Doxorubicin, Drug Evaluation, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MA Fischl
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA CARE Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
San Francisco AIDS Clinic / San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
331361013
Country
United States
Facility Name
Charity Hosp / Tulane Univ Med School
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Beth Israel Deaconess - West Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
SUNY / Erie County Med Ctr at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mem Sloan - Kettering Cancer Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Univ of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
8450401
Citation
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 (1988). 1993 Mar;6(3):259-64.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs