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| Sponsor: | Sequus Pharmaceuticals |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002319 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma, Kaposi HIV Infections |
Drug: Doxorubicin hydrochloride (liposomal) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Safety Study |
| Official Title: | Open Trial of DOX-SL (Stealth Liposomal Doxorubicin Hydrochloride) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma |
Patients receive DOX-SL every 3 weeks for a maximum of 20 cycles (including any cycles from a previous DOX-SL study). KS lesions are evaluated prior to administration of each treatment, at the end of the final treatment cycle, and at 4 weeks following the end of the final treatment. Patients who respond will be followed every 2 months for up to 1 year. Study treatment may be interrupted for up to 4 months because of complete response, development of opportunistic infections, or adverse drug effects.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded within the past 4 weeks:
Prior Treatment:
Excluded within the past 3 weeks:
Contacts and Locations
Hide Study Locations| United States, California | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| Kaiser Permanente Med Ctr | |
| San Francisco, California, United States, 94115 | |
| Dr Becky Miller | |
| Los Angeles, California, United States, 90048 | |
| Pacific Oaks Med Group | |
| Beverly Hills, California, United States, 90211 | |
| UCSF | |
| San Francisco, California, United States, 94117 | |
| Apogee Med Group | |
| San Diego, California, United States, 92103 | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Hematology - Oncology Med Group of San Fernando Valley | |
| Encino, California, United States, 91436 | |
| UCSF | |
| San Francisco, California, United States, 941430324 | |
| Pacific Oaks Med Group | |
| Sherman Oaks, California, United States, 91403 | |
| East Bay AIDS Ctr | |
| Berkeley, California, United States, 94705 | |
| United States, District of Columbia | |
| Dr Mahmoud Mustafa | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| H Lee Moffit Cancer Ctr and Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| American Med Research Institute | |
| Atlanta, Georgia, United States, 30329 | |
| Infectious Disease Rsch Consortium of GA / SE Clin Resources | |
| Atlanta, Georgia, United States, 30345 | |
| United States, Illinois | |
| Rush Presbyterian Med College | |
| Chicago, Illinois, United States, 60612 | |
| Illinois Masonic Med Ctr / The Cancer Ctr | |
| Chicago, Illinois, United States, 60657 | |
| Northwestern Med Faculty Foundation | |
| Chicago, Illinois, United States, 60611 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| United States, Missouri | |
| Washington Univ | |
| St. Louis, Missouri, United States, 63108 | |
| United States, New York | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10023 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Mount Sinai Med Ctr | |
| New York, New York, United States, 10029 | |
| Mem Sloan - Kettering Cancer Ctr | |
| New York, New York, United States, 10021 | |
| United States, Pennsylvania | |
| Graduate Hosp / Tuttleman Cancer Ctr | |
| Philadelphia, Pennsylvania, United States, 19146 | |
| United States, Texas | |
| Comprehensive Care Ctr | |
| Dallas, Texas, United States, 75235 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Twelve Oaks Hosp | |
| Houston, Texas, United States, 77074 | |
| Houston Immunological Institute | |
| Houston, Texas, United States, 77054 | |
| United States, Washington | |
| Virginia Mason Research Center / Clinical Trial Unit | |
| Seattle, Washington, United States, 98101 | |
More Information
| Study ID Numbers: | 134C, LTI-30-12 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002319 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sarcoma, Kaposi Liposomes Doxorubicin Acquired Immunodeficiency Syndrome Drug Carriers |
|
Sexually Transmitted Diseases, Viral Slow Virus Diseases Antineoplastic Agents Infection Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Therapeutic Uses Neoplasms, Vascular Tissue Retroviridae Infections RNA Virus Infections Neoplasms by Histologic Type Immune System Diseases Sarcoma, Kaposi |
Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Doxorubicin Pharmacologic Actions Herpesviridae Infections Virus Diseases Neoplasms HIV Infections Sexually Transmitted Diseases Lentivirus Infections Sarcoma DNA Virus Infections |