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Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00107913
Recruitment Status : Unknown
Verified April 2005 by Hematology and Oncology Specialists.
Recruitment status was:  Recruiting
First Posted : April 12, 2005
Last Update Posted : June 24, 2005
Information provided by:
Hematology and Oncology Specialists

Brief Summary:
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 or disease Intervention/treatment Phase
Autoimmune Thrombocytopenic Purpura Drug: Doxil Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Study Start Date : September 2001
Study Completion Date : April 2005

Primary Outcome Measures :
  1. the primary outcome would be a platelet response, with a return of platelet count to normal

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  • Pregnant or lactating women.
  • Presence of a malignancy other than basal cell carcinoma of the skin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00107913

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United States, Louisiana
Hematology and Oncology Specialists Recruiting
Metairie, Louisiana, United States, 70006
Contact: Mary Ann Ostroske, RN    504-894-7115 ext 221   
Contact: Avri Haggerty, MT    504-883-2968   
Principal Investigator: Thomas M Cosgriff, MD         
Sponsors and Collaborators
Hematology and Oncology Specialists
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Principal Investigator: Thomas M Cosgriff, MD Hematology and Oncology Specialists

Layout table for additonal information Identifier: NCT00107913     History of Changes
Other Study ID Numbers: HOS1
First Posted: April 12, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2005
Keywords provided by Hematology and Oncology Specialists:
Immune Thrombocytopenic Purpura
Additional relevant MeSH terms:
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Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action