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

Sponsor:	M.D. Anderson Cancer Center
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 Graft Versus Host Disease	Drug: Recombinant Human Keratinocyte Growth Factor	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Uncontrolled 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:

Estimated Enrollment:	25
Study Start Date:	October 2000

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 microvilla and has a smooth intestinal boarder. This is frequently subject to superinfections from bacteria all of which cause the diarrhea to continue. Our 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

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.

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

More Information

No publications provided

Study ID Numbers:	ID00-036
Study First Received:	June 5, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00038792 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Mitosis Modulators

Mitogens
Graft vs Host Disease
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 18, 2010