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Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
This study has been completed.
Sponsored by: Fred Hutchinson Cancer Research Center
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00016458
  Purpose

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.


Condition Intervention Phase
Systemic Sclerosis
Drug: anti-thymocyte globulin
Drug: cyclophosphamide
Phase II

MedlinePlus related topics: Scleroderma
Drug Information available for: Cyclophosphamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 20
Study Start Date: June 2000
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.

  Eligibility

Ages Eligible for Study:   up to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016458

Locations
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Leona Holmberg Fred Hutchinson Cancer Research Center
  More Information

Study ID Numbers: 199/15818, FHCRC-1473.00
Study First Received: May 6, 2001
Last Updated: September 2, 2008
ClinicalTrials.gov Identifier: NCT00016458  
Health Authority: Unspecified

Keywords provided by Office of Rare Diseases (ORD):
arthritis & connective tissue diseases
rare disease
systemic sclerosis

Study placed in the following topic categories:
Antilymphocyte Serum
Skin Diseases
Arthritis
Rare Diseases
Connective Tissue Diseases
Scleroderma, Diffuse
Sclerosis
Scleroderma, Systemic
Cyclophosphamide
Diffuse systemic sclerosis
Scleroderma, diffuse

Additional relevant MeSH terms:
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009