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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2005 by Hematology and Oncology Specialists.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hematology and Oncology Specialists

ClinicalTrials.gov Identifier:

NCT00107913

First received: April 11, 2005

Last updated: June 23, 2005

Last verified: April 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

April 11, 2005

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00107913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Autoimmune Thrombocytopenic Purpura

Intervention ^ICMJE

Drug: Doxil

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

April 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00107913

Other Study ID Numbers ^ICMJE

HOS1

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

Hematology and Oncology Specialists

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thomas M Cosgriff, MD

Hematology and Oncology Specialists

Information Provided By

Hematology and Oncology Specialists

Verification Date

April 2005

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

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