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



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

For Condition: Acute Graft Versus Host Disease
Status: Terminated
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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.
Total Enrollment: 25

Location and Contact Information:

MD Anderson Cancer Center
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:
  ID00-036; 
Study Start Date: October 2000
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038792

Other Acute Graft Versus Host Disease Studies:
1. Phase I/II trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD

2. Dose-finding study using pentostatin for injection in the treatment of steroid-refractory aGvHD

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

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