Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
|ClinicalTrials.gov Identifier: NCT00016458|
Recruitment Status : Completed
First Posted : May 7, 2001
Last Update Posted : September 3, 2008
OBJECTIVES: I. Determine the toxicity of cyclophosphamide and rabbit anti-thymocyte globulin in patients with diffuse systemic sclerosis.
II. Determine the efficacy of this regimen in terms of controlling disease in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis||Drug: anti-thymocyte globulin Drug: cyclophosphamide||Phase 2|
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and rabbit anti-thymocyte globulin IV over 6-8 hours on days 2-5.
Patients are followed on days 60-85 and then every 3 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Study Start Date :||June 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016458
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Leona Holmberg||Fred Hutchinson Cancer Research Center|