Clinical trial · Interventional
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
NCT00000996CI-TRIAL-00054888completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Sarcoma, Kaposi | Kaposi Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDWalker 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)
- BACKGROUNDFischl 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. PMID 8450401