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

Primary Purpose

Sarcoma, Kaposi, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Doxorubicin hydrochloride (liposomal)
Sponsored by
Sequus Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma, Kaposi focused on measuring Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sequus Pharmaceutical Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Sequus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00002147
Brief Title
Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
Official Title
Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
Study Type
Interventional

2. Study Status

Record Verification Date
January 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sequus Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
Patients receive DOX-SL every 3 weeks for up to 20 cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Kaposi, HIV Infections
Keywords
Sarcoma, Kaposi, Liposomes, Doxorubicin, Acquired Immunodeficiency Syndrome, Drug Carriers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Doxorubicin hydrochloride (liposomal)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Sequus Pharmaceutical Inc
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States

12. IPD Sharing Statement

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

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