Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis
Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Sclerosis
Intervention: anti-thymocyte globulin (Drug); cyclophosphamide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s): Leona Holmberg, Study Chair, Affiliation: Fred Hutchinson Cancer Research Center
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.
Clinical Details
Study design: Primary Purpose: Treatment
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
Minimum age: N/A.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
University of Colorado Cancer Center, Denver, Colorado 80262, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States
Additional Information
Starting date: June 2000
Last updated: September 2, 2008
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