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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002147
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1996

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002147 on ClinicalTrials.gov Archive Site
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Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.
Use of Stealth Liposomal Doxorubicin HCl ( DOX-SL ) in the Treatment of Moderate to Severe AIDS-Related Kaposi's Sarcoma.

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.

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

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
  • Sarcoma, Kaposi
  • HIV Infections
Drug: Doxorubicin hydrochloride (liposomal)
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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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002147
134D, LTI-30-25
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Sequus Pharmaceuticals
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NIH AIDS Clinical Trials Information Service
January 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP