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

Completed · Phase 3

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002319

Run by

Sequus Pharmaceuticals

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 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.

You may not qualify if…

• 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.

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
• Mem Sloan - Kettering Cancer Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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