Phase II Study of Weekly Doxorubicin Treatment of AIDS Associated Kaposi's Sarcoma
Doxorubicin hydrochloride
Blood-Borne Infections+21
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, United StatesGeorge Washington Univ Med Ctr
Washington D.C., United StatesUniv of Miami School of Medicine
Miami, United States