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

Primary Purpose

Systemic Sclerosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
cyclophosphamide
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring arthritis & connective tissue diseases, rare disease, systemic sclerosis

Eligibility Criteria

undefined - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Cancer Center
  • Duke University Medical Center
  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
September 2, 2008
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00016458
Brief Title
Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis
Keywords
arthritis & connective tissue diseases, rare disease, systemic sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide

10. Eligibility

Sex
All
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leona Holmberg
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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