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.
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.
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: