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

This study is currently recruiting participants.

Verified by Hematology and Oncology Specialists, April 2005

Sponsored by:	Hematology and Oncology Specialists
Information provided by:	Hematology and Oncology Specialists
ClinicalTrials.gov Identifier:	NCT00107913

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	Intervention	Phase
Autoimmune Thrombocytopenic Purpura	Drug: Doxil	Phase II

Genetics Home Reference related topics: hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

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 as provided by Hematology and Oncology Specialists:

Primary Outcome Measures:

the primary outcome would be a platelet response, with a return of platelet count to normal

Estimated Enrollment:	10
Study Start Date:	September 2001
Estimated Study Completion Date:	April 2005

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107913

Locations

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

Sponsors and Collaborators

Hematology and Oncology Specialists

Investigators

Principal Investigator:

Thomas M Cosgriff, MD

Hematology and Oncology Specialists

More Information

Study ID Numbers:	HOS1
Study First Received:	April 11, 2005
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00107913
Health Authority:	United States: Institutional Review Board

Keywords provided by Hematology and Oncology Specialists:

Immune Thrombocytopenic Purpura

Study placed in the following topic categories:

Purpura
Autoimmune Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemostatic Disorders
Doxorubicin

Purpura, Thrombocytopenic
Signs and Symptoms
Thrombocytopathy
Thrombocytopenia
Hemorrhagic Disorders
Thrombocytopenic purpura, autoimmune
Purpura, Thrombocytopenic, Idiopathic

Additional relevant MeSH terms:

Skin Manifestations
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009