NCT00038792

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2000

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

June 5, 2002

Last Update Submit

August 1, 2012

Conditions

Acute Graft Versus Host Disease

Keywords

Acute Graft Versus Host DiseaseRefractory

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with resolution of diarrhea

    12 months

Study Arms (1)

aGvHD

EXPERIMENTAL
Drug: Recombinant Human Keratinocyte Growth Factor

Interventions

Recombinant Human Keratinocyte Growth FactorDRUG
aGvHD

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Fibroblast Growth Factor 7

Intervention Hierarchy (Ancestors)

Fibroblast Growth FactorsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • James L. Gajewski, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 7, 2002

Study Start

October 1, 2000

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(1)