CompletedPhase 2

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

United States48 participants

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00000996

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Sarcoma, Kaposi trials