A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma

Status unconfirmed · Phase 3

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.

Key facts

Study ID

NCT00002318

Run by

Sequus Pharmaceuticals

People needed

225

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Medication:
• Allowed:
• Prophylaxis for PCP, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., AZT, ddC, ddI) provided these doses have been stable for at least 1 month.
• Therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy.
• Foscarnet for new episodes of cytomegalovirus infection.
• Colony-stimulating factors and erythropoietin.
• Patients must have:
• Biopsy-proven, progressive, AIDS-related Kaposi's sarcoma, with any of the following:
• At least 25 mucocutaneous lesions.
• Ten or more new lesions in the prior month.
• Documented visceral disease with at least two accessible cutaneous lesions.
• Two accessible cutaneous lesions with edema.
• Documented anti-HIV antibody.
• No active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, Pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs).
• Life expectancy > 4 months.
• NOTE:
• Patients who respond to therapy on this protocol, as well as those who fail the ABV combination, are eligible to enter the Liposome Technology open trial using DOX-SL alone.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Clinically significant cardiac, hepatic, or renal disease.
• Peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss.
• Inability to comply with the study.
• Concurrent Medication:
• Excluded:
• Other cytotoxic chemotherapy.
• Ganciclovir.
• Patients with the following prior conditions are excluded:
• Prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function.
• History of idiosyncratic or allergic reaction to bleomycin or vincristine.
• Prior Medication:
• Excluded:
• Prior anthracycline therapy.
• Cytotoxic chemotherapy or interferon treatment within the past 4 weeks.
• Prior Treatment:
• Excluded:
• Radiation or electron beam therapy within the past 3 weeks.

Where it is running

• East Bay AIDS Ctr — Berkeley, California, United States
• Pacific Oaks Med Group — Beverly Hills, California, United States
• Hematology - Oncology Med Group of San Fernando Valley — Encino, California, United States
• Dr Becky Miller — Los Angeles, California, United States
• Apogee Med Group — San Diego, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Kaiser Permanente Med Ctr — San Francisco, California, United States
• UCSF — San Francisco, California, United States
• San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
• UCSF — San Francisco, California, United States
• Pacific Oaks Med Group — Sherman Oaks, California, United States
• Dr Mahmoud Mustafa — Washington D.C., District of Columbia, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• H Lee Moffit Cancer Ctr and Research Institute — Tampa, Florida, United States
• American Med Research Institute — Atlanta, Georgia, United States
• Infectious Disease Rsch Consortium of GA / SE Clin Resources — Atlanta, Georgia, United States
• Northwestern Med Faculty Foundation — Chicago, Illinois, United States
• Rush Presbyterian Med College — Chicago, Illinois, United States
• Illinois Masonic Med Ctr / The Cancer Ctr — Chicago, Illinois, United States
• Henry Ford Hosp — Detroit, Michigan, United States
• Washington Univ — St Louis, Missouri, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Saint Vincent's Hosp and Med Ctr — New York, New York, United States
• New York Univ Med Ctr — New York, New York, United States
• Saint Luke's - Roosevelt Hosp Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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