ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
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.

Sponsored by: 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

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

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride   

U.S. FDA Resources

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

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)
 

Study ID Numbers:   134D, LTI-30-25
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002147
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  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Doxorubicin
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Neoplasms
RNA Virus Infections
Neoplasms by Histologic Type
Slow Virus Diseases
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Vascular Tissue
Lentivirus Infections
Antibiotics, Antineoplastic
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers