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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Number of Participants with resolution of diarrhea [ Time Frame: 12 months ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: June 5, 2002
Date Started: October 2000
Date Completion:
Last Updated: August 1, 2012
Last Verified: August 2012