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Study of Doxil in the Treatment of Patients with Refractory Idiopathic Thrombocytopenic Purpura - Article


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Autoimmune Diseases

 




Clinical Trial: Study of Doxil in the Treatment of Patients with Refractory Idiopathic Thrombocytopenic Purpura

This study is currently recruiting patients.

Sponsored by: Hematology and Oncology Specialists
Information provided by: Hematology and Oncology Specialists

Purpose

This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).

Condition Treatment or Intervention Phase
Autoimmune Thrombocytopenic Purpura
 Drug: Doxil
Phase II

MedlinePlus related topics:  Autoimmune Diseases;   Bleeding Disorders;   Blood and Blood Disorders;   Immune System and Disorders

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title: Phase II Study of Doxil in the Treatment of Patients with Refractory Idiopathic Thrombocytopenic Purpura

Further Study Details: 
Primary Outcomes: the primary outcome would be a platelet response, with a return of platelet count to normal
Expected Total Enrollment:  10

Study start: September 2001;  Expected completion: April 2007
Last follow-up: April 2005;  Data entry closure: April 2006

Eligible patients will receive Doxil 20 mg/m2 IV over 1 hour every 2 weeks. Treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.

Eligibility

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes.
  • Failure to respond to initial treatment with steroids, IV immune globulin, splenectomy and post splenectomy steroids.
  • Platelet count of 30,000 or less.
  • Performance status score of 2 or less.
  • Adequate organ function: *bilirubin< 2; *AST < 3 times normal; *creatinine < 2.
  • No prior treatment with anthracycline or chemically related drugs.

Exclusion Criteria:


Location and Contact Information


Louisiana
      Hematology and Oncology Specialists, Metairie,  Louisiana,  70006,  United States; Recruiting
Mary Ann Ostroske, RN  504-894-7115  Ext. 221    mostroske1@salco.net 
Avri Haggerty, MT  504-883-2968    ahaggerty@salco.net 
Thomas M Cosgriff, MD,  Principal Investigator

Study chairs or principal investigators

Thomas M Cosgriff, MD,  Principal Investigator,  Hematology and Oncology Specialists   

More Information

Study ID Numbers:  HOS1
Record last reviewed:  April 2005
Last Updated:  April 12, 2005
Record first received:  April 11, 2005
ClinicalTrials.gov Identifier:  NCT00107913
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-14


Source: ClinicalTrials.gov
Cache Date: April 14, 2005


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Page Updated: September 6, 2005
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