Back to resultsStudy of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Primary Purpose
Autoimmune Thrombocytopenic Purpura
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Doxil
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Thrombocytopenic Purpura focused on measuring Immune Thrombocytopenic Purpura
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.
Sites / Locations
- Hematology and Oncology SpecialistsRecruiting
Outcomes
Primary Outcome Measures
the primary outcome would be a platelet response, with a return of platelet count to normal
Secondary Outcome Measures
Full Information
NCT ID
NCT00107913
First Posted
April 11, 2005
Last Updated
June 23, 2005
Sponsor
Hematology and Oncology Specialists
1. Study Identification
Unique Protocol Identification Number
NCT00107913
Brief Title
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Official Title
Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Study Type
Interventional
2. Study Status
Record Verification Date
April 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hematology and Oncology Specialists
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Thrombocytopenic Purpura
Keywords
Immune Thrombocytopenic Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Doxil
Primary Outcome Measure Information:
Title
the primary outcome would be a platelet response, with a return of platelet count to normal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas M Cosgriff, MD
Organizational Affiliation
Hematology and Oncology Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hematology and Oncology Specialists
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Ann Ostroske, RN
Phone
504-894-7115
Ext
221
Email
mostroske1@salco.net
First Name & Middle Initial & Last Name & Degree
Avri Haggerty, MT
Phone
504-883-2968
Email
ahaggerty@salco.net
First Name & Middle Initial & Last Name & Degree
Thomas M Cosgriff, MD
12. IPD Sharing Statement
Learn more about this trial
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
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