Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-02-24 @ 5:46 AM
Study NCT ID:
NCT00038792
Status:
TERMINATED
Last Update Posted:
2012-08-02
First Post:
2002-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D051523', 'term': 'Fibroblast Growth Factor 7'}], 'ancestors': [{'id': 'D005346', 'term': 'Fibroblast Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Slow accrual.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2002-06-05', 'studyFirstSubmitQcDate': '2002-06-06', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with resolution of diarrhea', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Graft Versus Host Disease', 'Refractory'], 'conditions': ['Acute Graft Versus Host Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'UT MD Anderson Cancer Center website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* 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.\n* Patients may have skin or liver involvement with graft versus host disease.\n* Patients should not have any infections etiology for diarrhea.\n\nExclusion criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00038792', 'briefTitle': 'Phase I/II Trial rHuKFG for the Treatment of Steroid Refractory Gastrointestinal Acute GVHD', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ID00-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aGvHD', 'interventionNames': ['Drug: Recombinant Human Keratinocyte Growth Factor']}], 'interventions': [{'name': 'Recombinant Human Keratinocyte Growth Factor', 'type': 'DRUG', 'armGroupLabels': ['aGvHD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'James L. Gajewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UT MD Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amgen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}