Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

This study is ongoing, but not recruiting participants.

First Received: March 25, 2003 Last Updated: February 8, 2006 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development University of Michigan
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00056875

Purpose

This is a single arm dose escalation study of recombinant human keratinocyte growth factor given to patients undergoing allogeneic bone marrow transplantation who are at high risk for graft versus host disease (GVHD).

Condition	Intervention	Phase
Graft Versus Host Disease	Drug: recombinant human keratinocyte growth factor	Phase I Phase II

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Historical Control, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Transplantation

Drug Information available for: Fibroblast growth factor 7 Palifermin

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	50
Study Start Date:	September 2002
Estimated Study Completion Date:	April 2004

Eligibility

Ages Eligible for Study:	3 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Eligible for full intensity bone marrow transplant (BMT) conditioning but who lack a 6/6 HLA idential sibling donor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056875

Locations

United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of Michigan

Investigators

Principal Investigator:

John Levine, MD

Univeristy of Michigan

More Information

No publications provided

Study ID Numbers:	2146
Study First Received:	March 25, 2003
Last Updated:	February 8, 2006
ClinicalTrials.gov Identifier:	NCT00056875 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

graft versus host disease
bone marrow transplant
alternative donor

Study placed in the following topic categories:

Graft Versus Host Disease
Mitogens
Graft vs Host Disease
Homologous Wasting Disease

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Mitosis Modulators

Mitogens
Graft vs Host Disease
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009