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

NCT00040651 | Terminated Phase 1

• 2 other identifiers: N01 AR92239NIAMS-047
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Scleroderma; Systemic Sclerosis

Keywords

Systemic Sclerosis; Chemotherapy; Cyclophosphamide; Fludarabine; Leukapheresis; Mesna; Stem Cell; T-Cell; Thymoglobulin; Scleroderma

Outcome Measures

Primary Outcomes (1)

• Non-hematologic toxicity experienced

  Measured within 3 weeks after transplant

Secondary Outcomes (1)

• Clinical and laboratory responses to chemotherapy and self bone marrow transplant

  Measured at 12 and 24 months after transplant

Interventions

Fludarabine DRUG

Cyclophosphamide DRUG

Thymoglobulin DRUG

Leukapheresis PROCEDURE

Self bone marrow transplant PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead
• University of Pittsburgh: collaborator
• Amgen: collaborator
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Interventions

fludarabine; Cyclophosphamide; thymoglobulin; Leukapheresis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Robert Herberman, MD

  UPMC Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 5, 2002
• First Posted: July 10, 2002
• Study Start: July 1, 2002
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: December 28, 2007

Record last verified: 2007-12

Locations

US (1)