Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

This study has been completed.

First Received on November 2, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	Sequus Pharmaceuticals
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002147

Purpose

To provide Stealth liposomal doxorubicin hydrochloride ( DOX-SL ) as a therapy for Kaposi's sarcoma patients who have no remaining treatment options other than DOX-SL or patients who have been participating in another DOX-SL protocol and for whom continuation in DOX-SL is medically indicated. Also, to evaluate the safety and efficacy of DOX-SL in patients with Kaposi's sarcoma who have previously received systemic chemotherapy with or without an anthracycline.

Condition	Intervention	Phase
Sarcoma, Kaposi HIV Infections	Drug: Doxorubicin hydrochloride (liposomal)	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment
Official Title:	Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Patients receive DOX-SL every 3 weeks for up to 20 cycles.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients must have:

AIDS-related Kaposi's sarcoma that requires systemic chemotherapy.
EITHER a medical indication for continuation of DOX-SL following treatment on another DOX-SL protocol, OR no remaining treatment options other than DOX-SL.

Prior Medication:

Allowed:

Prior anthracyclines.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Cardiac ejection fraction < 50 percent or clinically significant cardiac disease.
Eligibility for a Liposomal Technology comparative protocol.

Concurrent Medication:

Excluded:

Other cytotoxic chemotherapy.

Patients with the following prior condition are excluded:

History of idiosyncratic or allergic reaction to anthracyclines.

Prior Medication:

Excluded:

Chemotherapy within the past 3 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002147

Locations

United States, California
Sequus Pharmaceutical Inc
Menlo Park, California, United States, 94025

Sponsors and Collaborators

Sequus Pharmaceuticals

More Information

Publications:

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)

ClinicalTrials.gov Identifier:	NCT00002147 History of Changes
Other Study ID Numbers:	134D, LTI-30-25
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Sarcoma, Kaposi
Liposomes
Doxorubicin
Acquired Immunodeficiency Syndrome
Drug Carriers

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Sarcoma
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Herpesviridae Infections
DNA Virus Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
Parasitic Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012