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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 1/Phase 2
N/A
N/A
Not Enrolling
Both
Acute Graft Versus Host Disease

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Trial Information

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)


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.

Inclusion 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:

- None

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with resolution of diarrhea

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

James L. Gajewski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID00-036

NCT ID:

NCT00038792

Start Date:

October 2000

Completion Date:

January 2003

Related Keywords:

  • Acute Graft Versus Host Disease
  • Acute Graft Versus Host Disease
  • Refractory
  • Graft vs Host Disease

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096