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

Systemic Sclerosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016458
• Other study ID #: 199/15818
• Secondary ID: FHCRC-1473.00
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2001
• Last updated: September 2, 2008
• Start date: June 2000

Study information

• Verified date: September 2008
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 64 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• anti-thymocyte globulin

• cyclophosphamide

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States,