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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. The completion date has passed and the status has not been verified in more than two years.
Verified April 2005 by Hematology and Oncology Specialists.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00107913
First Posted: April 12, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hematology and Oncology Specialists
  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
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00107913     History of Changes
Other Study ID Numbers: HOS1
First Submitted: April 11, 2005
First Posted: April 12, 2005
Last Update Posted: December 9, 2005
Last Verified: April 2005

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
Liposomal doxorubicin
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action