Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Scleroderma, or systemic sclerosis (SSc), is a diffuse connective tissue disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. The purpose of this study is to determine the safety and value of self bone marrow transplants after chemotherapy in patients with severe SSc.

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

Details

• Lead Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Collaborators: Amgen; Genzyme, a Sanofi Company; University of Pittsburgh
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Thymoglobulin

Criteria

Inclusion Criteria:

• ECOG performance status of 0 to 2

• Willing to participate in all portions of the protocol, including pharmacodynamic and immunologic studies and patient care follow-up visits

• Willing to stay in the Pittsburgh area for 100 days post-transplantation

• Willing to use acceptable methods of contraception

Exclusion Criteria:

• HIV infected

• Hepatitis C virus infected

• Active infection

• Small malabsorption syndrome

• Immunosuppressive therapy other than steroids within 4 weeks of study entry

• Pregnant or breastfeeding