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Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD

This study has been terminated.
(Slow accrual.)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: June 5, 2002
Last updated: August 1, 2012
Last verified: August 2012
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 1
Phase 2

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

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 ]

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00038792

United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: James L. Gajewski, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038792     History of Changes
Other Study ID Numbers: ID00-036
Study First Received: June 5, 2002
Last Updated: August 1, 2012

Keywords provided by M.D. Anderson Cancer Center:
Acute Graft Versus Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 26, 2017