Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the NCT00002147

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00002147
Other study ID #	134D
Secondary ID	LTI-30-25
Status	Completed
Phase	Phase 3
First received	November 2, 1999
Last updated	June 23, 2005

Study information
Verified date	January 1996
Source	NIH AIDS Clinical Trials Information Service
Contact	n/a
Is FDA regulated	No
Health authority	United States: Food and Drug Administration
Study type	Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status	Completed
Enrollment	0
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	18 Years and older
Eligibility	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.

Study Design

Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Doxorubicin hydrochloride (liposomal)

Locations
Country	Name	City	State
United States	Sequus Pharmaceutical Inc	Menlo Park	California

Sponsors *(1)*
Lead Sponsor	Collaborator
Sequus Pharmaceuticals

Country where clinical trial is conducted

United States,

References & 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)

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

Clinical Trial Details — Status: Completed

Administrative data

Study information