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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Sclerosis

Intervention: anti-thymocyte globulin (Drug); cyclophosphamide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
Leona Holmberg, Study Chair, Affiliation: Fred Hutchinson Cancer Research Center


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.

Clinical Details

Study design: Primary Purpose: Treatment

Detailed description: 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.


Minimum age: N/A. Maximum age: 64 Years. Gender(s): Both.



- -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

Locations and Contacts

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

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

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

Additional Information

Starting date: June 2000
Last updated: September 2, 2008

Page last updated: August 20, 2015

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