Status:
UNKNOWN
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Lead Sponsor:
Hematology and Oncology Specialists
Conditions:
Autoimmune Thrombocytopenic Purpura
Eligibility:
All Genders
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- Pregnant or lactating women.
- Presence of a malignancy other than basal cell carcinoma of the skin.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00107913
Start Date
September 1 2001
End Date
April 1 2005
Last Update
June 24 2005
Active Locations (1)
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1
Hematology and Oncology Specialists
Metairie, Louisiana, United States, 70006