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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Treatment |
Eligibility| Ages Eligible for Study: | up to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and 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 | |
| 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 History of Changes |
| Health Authority: | Unspecified |
|
arthritis & connective tissue diseases rare disease systemic sclerosis |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Sclerosis Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions Antilymphocyte Serum |
Pathologic Processes Therapeutic Uses Myeloablative Agonists Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |