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

• Status: Terminated
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Amgen
• Treatments: Mitogens

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