Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
|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.|
|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)|
|Enrollment :||20 participants|
|Study Start Date :||June 2000|
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): 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|