Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Amgen
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038792

Purpose

Phase II efficacy evaluation, phase I/II efficacy and toxicity trial of recombinant human keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft versus host disease.

Condition	Intervention	Phase
Acute GVH Disease	Drug: Recombinant Human Keratinocyte Growth Factor	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I/II Trial of Recombinant Human Keratinocyte Growth Factor (rHuKFG) for the Treatment of Steroid Refractory Gastrointestinal Acute Graft-versus-host Disease (aGvHD)

Resource links provided by NLM:

Drug Information available for: Fibroblast growth factor 7 Palifermin

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Number of Participants with resolution of diarrhea [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	October 2000
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: aGvHD	Drug: Recombinant Human Keratinocyte Growth Factor

Detailed Description:

There are two processes that cause diarrhea as the clinical manifestation of graft versus host disease. The first is the obvious immunologic attack on the colonic epithelium of the recipient. Once this immunologic attack has been abated the recipient is left with a colonic mucosa that is devoid of microvilli and has a smooth intestinal boarder. This is frequently subject to superinfections from bacteria all of which cause the diarrhea to continue. Researchers only endpoint to measure clinical response of immunosuppression is the resolution of diarrhea. The human recombinant keratinocyte growth factor stimulates the growth of colonic epithelium. The growth of colonic epithelium will in turn probably ameliorate some of the diarrhea associated with graft versus host disease.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Patients post allogeneic bone marrow transplant with watery diarrhea progressed on 2mg/kg of steroids after 3 days or failed to improve after 5 days.
Patients may have skin or liver involvement with graft versus host disease.
Patients should not have any infections etiology for diarrhea.

Exclusion criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038792

Locations

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Amgen

Investigators

Principal Investigator:

James L. Gajewski, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	James L.Gajewski, MD, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038792 History of Changes
Other Study ID Numbers:	ID00-036
Study First Received:	June 5, 2002
Last Updated:	March 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Acute Graft Versus Host Disease
Refractory

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