Status:
COMPLETED
Scleroderma: Cyclophosphamide or Transplantation
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Rho Federal Systems Division, Inc.
Conditions:
Scleroderma, Systemic
Sclerosis
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
PHASE3
Brief Summary
SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT stands for Scleroderma: Cyclophosphamide Or Transplantation. The SCOT study will compare the potential bene...
Detailed Description
Severe systemic sclerosis (SSc) is a serious autoimmune disorder in which a person's own immune cells attack organs in the body. SSc affects the skin, joints, lungs, heart, intestinal tract, and kidne...
Eligibility Criteria
Inclusion
- Severe systemic sclerosis (SSc) as defined by the American College of Rheumatology (ACR);
- SSc, including extensive skin and internal organ involvement involving either the lungs or the kidneys, that threatens participant's life; and
- Willingness to use accepted methods of contraception for at least 15 months after starting study treatment.
Exclusion
- Lung, heart, liver, or kidney impairment that would interfere with the study or compromise participant's survival;
- Active blood vessel dilation in the stomach (Active Gastric Antral Vascular Ectasia/GAVE, also known as "watermelon stomach"). Patients found to have this disorder at study screening can receive treatment outside the study and then be re-screened. For more information about this study criterion, refer to the study protocol.
- Previous treatment with cyclophosphamide, as defined by: a) prior IV cyclophosphamide administration for more than 6 months OR a total cumulative IV dose greater than 3 g/m\^2; b) prior oral cyclophosphamide administration for more than 4 months, regardless of dose; or c) combination of prior oral and IV cyclophosphamide administration for more than 6 months, independent of dose.
- Steroid therapy at doses of greater than 10 mg/day, or more than 2 pulses for concurrent illnesses within prior 12 months;
- Unwillingness or inability to discontinue certain disease-modifying antirheumatic drugs (DMARDs) for the treatment of SSc;
- Presence of clinically significant rheumatic diseases other than scleroderma requiring significant immunosuppression;
- Any active uncontrolled infection that would interfere with high-dose therapy or pulse cyclophosphamide regimens:
- Hepatitis B virus infected
- Hepatitis C virus infected or
- HIV infected.
- Blood abnormalities;
- Diagnosis of cancer within 2 years prior to study entry. Participants with adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ are not excluded.
- Other comorbid illnesses with an estimated life expectancy of less than 5 years;
- Defective formation of bone marrow cells (myelodysplasia);
- Uncontrolled hypertension;
- History of hypersensitivity to murine or Escherichia coli (e.g., E. coli) proteins; History of noncompliance with prior medical care;
- History of substance abuse within 5 years prior to study entry; or
- Pregnancy.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00114530
Start Date
June 1 2005
End Date
April 1 2016
Last Update
April 12 2023
Active Locations (17)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
2
UCLA Medical School
Los Angeles, California, United States, 90095-1670
3
University of Kentucky
Lexington, Kentucky, United States, 40536-0284
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114