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

• Status: Unknown status
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hematology and Oncology Specialists
• Treatments: Doxorubicin; Liposomal doxorubicin

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.