To evaluate the safety and effectiveness of Stealth liposomal doxorubicin hydrochloride
(DOX-SL) in the long-term treatment of AIDS-related Kaposi's sarcoma (KS) in patients who
previously had good responses to DOX-SL in controlled studies of limited duration, or those
with KS who discontinued treatment with another Kaposi's sarcoma therapy because of
inadequate efficacy or unacceptable toxicity. To provide a defined protocol for Kaposi's
sarcoma patients for whom DOX-SL therapy is indicated.
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.
UCSF - San Francisco Gen Hosp, San Francisco, California 94110, United States
Kaiser Permanente Med Ctr, San Francisco, California 94115, United States
Dr Becky Miller, Los Angeles, California 90048, United States
Pacific Oaks Med Group, Beverly Hills, California 90211, United States
Hematology - Oncology Med Group of San Fernando Valley, Encino, California 91436, United States
Apogee Med Group, San Diego, California 92103, United States
San Francisco Veterans Administration Med Ctr, San Francisco, California 94121, United States
UCSF, San Francisco, California 94117, United States
UCSF, San Francisco, California 941430324, United States
Pacific Oaks Med Group, Sherman Oaks, California 91403, United States
East Bay AIDS Ctr, Berkeley, California 94705, United States
Dr Mahmoud Mustafa, Washington, District of Columbia 20037, United States
Univ of Miami School of Medicine, Miami, Florida 33136, United States
H Lee Moffit Cancer Ctr and Research Institute, Tampa, Florida 33612, United States
American Med Research Institute, Atlanta, Georgia 30329, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources, Atlanta, Georgia 30345, United States
Rush Presbyterian Med College, Chicago, Illinois 60612, United States
Illinois Masonic Med Ctr / The Cancer Ctr, Chicago, Illinois 60657, United States
Northwestern Med Faculty Foundation, Chicago, Illinois 60611, United States
Henry Ford Hosp, Detroit, Michigan 48202, United States
Washington Univ, St. Louis, Missouri 63108, United States
Roswell Park Cancer Institute, Buffalo, New York 14263, United States
New York Univ Med Ctr, New York, New York 10016, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10023, United States
Saint Vincent's Hosp and Med Ctr, New York, New York 10011, United States
Mount Sinai Med Ctr, New York, New York 10029, United States
Mem Sloan - Kettering Cancer Ctr, New York, New York 10021, United States
Graduate Hosp / Tuttleman Cancer Ctr, Philadelphia, Pennsylvania 19146, United States
Comprehensive Care Ctr, Dallas, Texas 75235, United States
Baylor College of Medicine, Houston, Texas 77030, United States
Twelve Oaks Hosp, Houston, Texas 77074, United States
Houston Immunological Institute, Houston, Texas 77054, United States
Virginia Mason Research Center / Clinical Trial Unit, Seattle, Washington 98101, United States
Jablonowski H, Szelenyi H, Armbrecht C, Mauss S, Niederau C, Strohmeyer G. Liposomal doxorubicin--a new formulation for the treatment of Kaposi's sarcoma: a study on safety and efficacy in AIDS patients. Int Conf AIDS. 1993 Jun 6-11;9(1):397 (abstract no PO-B12-1573)
