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

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ClinicalTrials.gov Identifier: NCT00038792
Recruitment Status : Terminated (Slow accrual.)
First Posted : June 7, 2002
Last Update Posted : August 2, 2012
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Acute Graft Versus Host Disease Drug: Recombinant Human Keratinocyte Growth Factor Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : October 2000
Actual Primary Completion Date : January 2003
Actual Study Completion Date : January 2003


Arm Intervention/treatment
Experimental: aGvHD Drug: Recombinant Human Keratinocyte Growth Factor



Primary Outcome Measures :
  1. Number of Participants with resolution of diarrhea [ Time Frame: 12 months ]


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

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038792


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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038792     History of Changes
Other Study ID Numbers: ID00-036
First Posted: June 7, 2002    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action