Scleroderma: Cyclophosphamide or Transplantation

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 benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan) in the treatment of scleroderma.

Conditions

• Scleroderma, Systemic
• Sclerosis
• Autoimmune Disease

Interventions

BIOLOGICAL

mHSCT

Hematopoietic progenitors were mobilized with G-CSF. After leukapheresis and CD34+ cell enrichment, the autologous product was cryopreserved. Fractionated TBI (800 cGy), CY (120 mg/kg) and equine antithymocyte globulin (90 mg/kg) were administered as previously reported (References provided in citation section of this ClinicalTrials.gov record: PubMed ID: 17452515 citation and 2.) PubMed ID: 12176878 citation).

DRUG

cyclophosphamide

An initial intravenous dose of 500 mg/m\^2 was followed by 11 infusions of 750 mg/m\^2 with mesna given for bladder protection.

Sponsors & Collaborators

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Keith M. Sullivan, MD · Duke University

• Daniel E. Furst, MD · University of California, Los Angeles Rheumatology

• Peter A. McSweeney, MD · Presbyterian/St. Luke's Medical Center:Rocky Mountain Cancer Center

• Leslie J. Crofford, MD · University of Kentucky, Women's Health Program: Rheumatology

• Maureen D. Mayes, MD, MPH · University of Texas - Houston Health Science Center

• Richard A. Nash, MD · Fred Hutchinson Cancer Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-06-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• United States
• Canada

Study Locations