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

NCT00016458 | Completed Phase 2

• 2 other identifiers: 199/15818FHCRC-1473.00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Systemic Sclerosis

Keywords

arthritis & connective tissue diseases; rare disease; systemic sclerosis

Interventions

anti-thymocyte globulin DRUG

cyclophosphamide DRUG

Eligibility Criteria

• Age: Up to 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (3)

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Arthritis; Connective Tissue Diseases; Rare Diseases

Interventions

Antilymphocyte Serum; Cyclophosphamide

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Leona Holmberg

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: May 7, 2001
• Study Start: June 1, 2000
• Last Updated: September 3, 2008

Record last verified: 2008-09

Locations

US (3)