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Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis



Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis

For Condition: Systemic Sclerosis
Status: No longer recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of diffuse systemic sclerosis Progressive disease Skin score at least 16 Interstitial or pulmonary vasculitis (FVC or DLCO no greater than 70% predicted) with evidence of alveolitis by bronchoalveolar lavage (BAL) Proteinuria (more than 500 mg/24 hours) Rapid deterioration in pulmonary function (at least 15% decrease in FVC or DLCO within the past 6 months) or new evidence of alveolitis by CT scan changes or BAL No acute renal failure secondary to systemic sclerosis crisis DLCO greater than 20% predicted Ineligible for or refused autologous or allogeneic peripheral blood stem cell or bone marrow transplantation --Prior/Concurrent Therapy-- 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
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
LeonaHolmberg,  Study Chair,  Fred Hutchinson Cancer Research Center

Fred Hutchinson Cancer Research Center
Seattle,  Washington,  98109
United States
 

University of Colorado Cancer Center
Denver,  Colorado,  80262
United States
 

Duke University Medical Center
Durham,  North Carolina,  27710
United States
 


Additional Information:
Study ID Numbers:  199/15818;  FHCRC-1473.00
Study Start Date: June 2000
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016458

Other Systemic Sclerosis Studies:
1. Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

2. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis

3. Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis

4. Genetic Study of the FBN1 Gene and Fibrillin-1 Abnormalities in Choctaw Native Americans and Other Patients with Systemic Sclerosis

5. Scleroderma Registry

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