Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Slow accrual.)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038792
First received: June 5, 2002
Last updated: August 1, 2012
Last verified: August 2012

June 5, 2002
August 1, 2012
October 2000
January 2003   (final data collection date for primary outcome measure)
Number of Participants with resolution of diarrhea [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00038792 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD
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)

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Graft Versus Host Disease
Drug: Recombinant Human Keratinocyte Growth Factor
Experimental: aGvHD
Intervention: Drug: Recombinant Human Keratinocyte Growth Factor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
January 2003
January 2003   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038792
ID00-036
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Amgen
Principal Investigator: James L. Gajewski, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP