Thalidomide for Decreasing Collagen Biosynthesis in People With Progressive Systemic Sclerosis

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Progressive systemic sclerosis (SSc) is an immune-based disease that causes abnormal connective tissue growth of the skin and internal organs. At this point, there are no effective therapies for treating SSc. Thalidomide is a medication that has been shown to stimulate an immune response that reduces the body's synthesis of collagen, the main component of connective tissue. This study will determine the effectiveness of thalidomide in treating adults with SSc.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

• Diagnosis of scleroderma

• Agrees to use an effective form of contraception for 1 month prior to study entry, throughout the study, and for 60 days after completing the study

• Positive serum anti-nuclear antibody titer

Exclusion Criteria:

• Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents or with other connective tissue diseases

• Significant existing damage to any of the following internal organs:

• Kidneys, defined as a serum creatinine level greater than 2 mg/dl or renal crisis

• Lungs, defined as needing supplemental oxygen

• Heart, defined as left ventricular ejection fraction less than or equal to 40%

• Gut, defined as pseudo-obstruction or malabsorption requiring total parental nutrition

• Concurrent interventional therapy that might independently influence the outcome of this trial (e.g., D-penicillamine, cyclosporine, interferon-γ, methotrexate, or photophorosis)

• Clinically significant and inadequately medically treated concurrent endocrine, blood, liver, lung, or kidney diseases

• Pregnant

• Recent drug or alcohol abuse

• Documented noncompliance

• Significant psychiatric history

• Therapy with another investigational drug within 4 weeks prior to study entry

• Screening laboratory results exceeding the following limits: hemoglobin level less than 7 gm/dl; white blood cell level less than 3,000/nl; platelet count less than 50/nl; alanine aminotransferase (ALT) level greater than 65 U/L; creatinine level greater than 2 mg/dl