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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
  Purpose

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).


Condition Intervention Phase
Autoimmune Thrombocytopenic Purpura
 Drug: Doxil
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hematology and Oncology Specialists:

Primary Outcome Measures:
  • the primary outcome would be a platelet response, with a return of platelet count to normal

Estimated Enrollment: 10
Study Start Date: September 2001
Estimated Study Completion Date: April 2005
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107913

Locations
United States, Louisiana
Hematology and Oncology Specialists Recruiting
Metairie, Louisiana, United States, 70006
Contact: Mary Ann Ostroske, RN     504-894-7115 ext 221     mostroske1@salco.net    
Contact: Avri Haggerty, MT     504-883-2968     ahaggerty@salco.net    
Principal Investigator: Thomas M Cosgriff, MD            
Sponsors and Collaborators
Hematology and Oncology Specialists
Investigators
Principal Investigator: Thomas M Cosgriff, MD Hematology and Oncology Specialists
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00107913     History of Changes
Other Study ID Numbers: HOS1
Study First Received: April 11, 2005
Last Updated: June 23, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by Hematology and Oncology Specialists:
Immune Thrombocytopenic Purpura

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
 Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013