Keratinocyte Growth Factor to Prevent Acute GVHD - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00031148

Purpose

This is a study to determine the safety and efficacy of keratinocyte growth factor (KGF) to prevent acute graft-versus-host disease (GVHD) in patients undergoing allogeneic bone marrow (BM) or peripheral blood progenitor cell (PBPC) transplantation.

Condition	Intervention	Phase
Graft-Vs-Host Disease	Drug: Recombinant Human Keratinocyte Growth Factor (rHuKGF)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Phase I/II Trial of Keratinocyte Growth Factor (rHuKGF) to Prevent Acute GVHD in 6/6 HLA=BMT Recipients

Resource links provided by NLM:

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:	72
Study Start Date:	September 2001
Estimated Study Completion Date:	August 2003

Detailed Description:

GVHD remains the major complication of allogeneic BM transplantation and is initiated during the conditioning of the recipient for transplant when the host tissues are damaged. Research has demonstrated that the gastrointestinal (GI) tract is a critical organ in GVHD pathophysiology. Agents that protect the GI tract may provide prophylaxis against the cytokine cascade and can lead to a reduced incidence and severity of GVHD. KGF is a protein that stimulates the growth of epithelial cells including those of the GI tract. KGF can protect the GI tract, prevent GVHD, and preserve donor T-cell function.

Patients will receive standard GVHD prophylaxis in addition to the study drug. Overall GVHD will be graded weekly during the first 2 months after transplant, then every other week to Day 100. Response to therapy will be measured through the use of severity indices, physical exam, and laboratory serum values.

Eligibility

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

Criteria

Inclusion criteria:

Diagnosis of a hematological malignancy, including myelodysplastic syndromes.
Eligible for cyclophosphamide and total body irradiation conditioning therapy or busulphan and cyclophosphamide conditioning therapy.
Must have a 6/6 human leukocyte antigens (HLA)-matched family member donor.
Women must be post-menopausal, sterile, or using effective contraception for 1 month before, during, and for 2 months after study.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Exclusion criteria:

T-cell depletion for GVHD prophylaxis.
Active hepatitis.
Pre-existent inflammatory bowel disease requiring active therapy.
Active uncontrolled infection.
Prior bone marrow or peripheral blood stem cell (PBSC) transplantation.
Documented hypersensitivity to rHuKGF.
Prior enrollment to a study of rHuKGF.
HIV-positive.
Pregnant or nursing.
Active chronic skin disease requiring therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031148

Locations

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

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00031148 History of Changes
Other Study ID Numbers:	FD-R-2021-01, FD-R-002021-01
Study First Received:	February 26, 2002
Last Updated:	January 31, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Keratinocyte growth factor
Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation

HLA Antigens
Transplantation, Homologous
Recombinant Proteins

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases
Mitogens

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012