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

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

Sponsors

Lead sponsor: Hematology and Oncology Specialists

Source 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).

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.

Overall Status Unknown status
Start Date September 2001
Completion Date April 2005
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
the primary outcome would be a platelet response, with a return of platelet count to normal
Enrollment 10
Condition
Intervention

Intervention type: Drug

Intervention name: Doxil

Eligibility

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.

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Thomas M Cosgriff, MD Principal Investigator Hematology and Oncology Specialists
Location
facility status contact contact_backup investigator Hematology and Oncology Specialists Mary Ann Ostroske, RN 504-894-7115 221 [email protected] Thomas M Cosgriff, MD Principal Investigator
Location Countries

United States

Verification Date

April 2005

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov