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Phase 2
64 Years
Not Enrolling
Systemic Sclerosis

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Trial Information

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.

Inclusion 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

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


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Leona Holmberg

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center



Study ID:




Start Date:

June 2000

Completion Date:

Related Keywords:

  • Systemic Sclerosis
  • arthritis & connective tissue diseases
  • rare disease
  • systemic sclerosis
  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Sclerosis



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
University of Colorado Cancer Center Denver, Colorado  80262
Duke University Medical Center Durham, North Carolina  27710