A Study of DOX-SL in the Treatment of AIDS-Related Kaposi's Sarcoma
Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma
2 other identifiers
interventional
N/A
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
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33 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
January 1, 1996
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
East Bay AIDS Ctr
Berkeley, California, 94705, 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
Dr Becky Miller
Los Angeles, California, 90048, United States
Apogee Med Group
San Diego, California, 92103, United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110, United States
Kaiser Permanente Med Ctr
San Francisco, California, 94115, United States
UCSF
San Francisco, California, 94117, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
UCSF
San Francisco, California, 941430324, United States
Pacific Oaks Med Group
Sherman Oaks, California, 91403, United States
Dr Mahmoud Mustafa
Washington D.C., 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
Northwestern Med Faculty Foundation
Chicago, Illinois, 60611, United States
Rush Presbyterian Med College
Chicago, Illinois, 60612, United States
Illinois Masonic Med Ctr / The Cancer Ctr
Chicago, Illinois, 60657, 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
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
New York Univ Med Ctr
New York, New York, 10016, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10023, United States
Mount Sinai Med Ctr
New York, New York, 10029, 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
Houston Immunological Institute
Houston, Texas, 77054, United States
Twelve Oaks Hosp
Houston, Texas, 77074, United States
Virginia Mason Research Center / Clinical Trial Unit
Seattle, Washington, 98101, United States
Related Publications (1)
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)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1996-01