Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
NCT ID: NCT00016458
Last Updated: 2008-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2000-06-30
Brief Summary
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II. Determine the efficacy of this regimen in terms of controlling disease in these patients.
Detailed Description
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Patients are followed on days 60-85 and then every 3 months for 1 year.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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anti-thymocyte globulin
cyclophosphamide
Eligibility Criteria
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Inclusion Criteria
Endocrine therapy: Concurrent prednisone allowed if prior chronic use
Other: At least 4 days since prior immunosuppressive therapy
--Patient Characteristics--
Performance status: Karnofsky 50-100%
Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin less than 2.5 times upper limit of normal (ULN) SGOT less than 2.5 times ULN
Renal: See Disease Characteristics Creatinine clearance at least 35 mL/min No requirement for renal dialysis
Cardiovascular: Ejection fraction greater than 45% No myocardial infarction within the past 12 months No unstable angina No uncontrolled cardiac arrhythmias No evidence of congestive heart failure
Pulmonary: See Disease Characteristics
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active uncontrolled infection
* No hypersensitivity to rabbit proteins
* No prior hemorrhagic cystitis requiring transfusion
* No concurrent active hemorrhagic cystitis by cystoscopy (if prior history)
* No concurrent malignancy
64 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Principal Investigators
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Leona Holmberg
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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University of Colorado Cancer Center
Denver, Colorado, United States
Duke University Medical Center
Durham, North Carolina, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1473.00
Identifier Type: -
Identifier Source: secondary_id
199/15818
Identifier Type: -
Identifier Source: org_study_id