A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
Sarcoma, Kaposi, HIV Infections
About this trial
This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy provided these doses have been stable for at least 1 month. Maintenance therapy for tuberculosis, fungal, and herpes infections. Therapy for new episodes of tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. Foscarnet or ganciclovir for CMV infection. Colony stimulating factors and erythropoietin. Patients must have: Moderate to severe AIDS-related Kaposi's sarcoma. Documented anti-HIV antibody. No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). NOTE: Eligible KS patients include those who have discontinued therapy in the control arm of a DOX-SL KS study because of side effects or inadequate efficacy OR other KS patients for whom DOX-SL is believed to be indicated. Patients must not be eligible for other Liposome Technology protocols comparing DOX-SL with established therapies. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Clinically significant cardiac disease. Confusion or disorientation. Concurrent Medication: Excluded: Other cytotoxic cancer chemotherapy. Patients with the following prior conditions are excluded: Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to an irreversibly compromised marrow function. History of idiosyncratic or allergic reaction to anthracyclines. History of major psychiatric illness. Prior Medication: Excluded within the past 4 weeks: Cytotoxic chemotherapy (other than in a qualifying Liposome Technology protocol). Interferon treatment. Prior Treatment: Excluded within the past 3 weeks: Radiation or electron beam therapy.
Sites / Locations
- East Bay AIDS Ctr
- Pacific Oaks Med Group
- Hematology - Oncology Med Group of San Fernando Valley
- Dr Becky Miller
- Apogee Med Group
- UCSF - San Francisco Gen Hosp
- Kaiser Permanente Med Ctr
- UCSF
- San Francisco Veterans Administration Med Ctr
- UCSF
- Pacific Oaks Med Group
- Dr Mahmoud Mustafa
- Univ of Miami School of Medicine
- H Lee Moffit Cancer Ctr and Research Institute
- American Med Research Institute
- Infectious Disease Rsch Consortium of GA / SE Clin Resources
- Northwestern Med Faculty Foundation
- Rush Presbyterian Med College
- Illinois Masonic Med Ctr / The Cancer Ctr
- Henry Ford Hosp
- Washington Univ
- Roswell Park Cancer Institute
- Saint Vincent's Hosp and Med Ctr
- New York Univ Med Ctr
- Mem Sloan - Kettering Cancer Ctr
- Saint Luke's - Roosevelt Hosp Ctr
- Mount Sinai Med Ctr
- Graduate Hosp / Tuttleman Cancer Ctr
- Comprehensive Care Ctr
- Baylor College of Medicine
- Houston Immunological Institute
- Twelve Oaks Hosp
- Virginia Mason Research Center / Clinical Trial Unit