Scleroderma: Cyclophosphamide or Transplantation
Completed · Phase 2/Phase 3
Conditions studied: Scleroderma, Systemic, Sclerosis, Autoimmune Disease
In brief
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 benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan) in the treatment of scleroderma.
Key facts
- Study ID
- NCT00114530
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 75
- Starts
- 2005-06-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2023-04-12
Who can join
Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- UCLA Medical School — Los Angeles, California, United States
- University of Kentucky — Lexington, Kentucky, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston University School of Medicine — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Toledo Health Science Campus — Toledo, Ohio, United States
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- University of Texas-Houston Medical School — Houston, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Fred Hutchinson Cancer Research Center (FHCRC) — Seattle, Washington, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- University of Calgary — Calgary, Alberta, Canada
- Dr. Markland Medical Professional Corporation — Saskatoon, Saskatchewan, Canada
Full record on ClinicalTrials.gov
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