Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00323518
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2006-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C416003', 'term': 'FGF20 protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'dispFirstSubmitDate': '2015-02-02', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2006-05-08', 'dispFirstSubmitQcDate': '2016-02-16', 'studyFirstSubmitQcDate': '2006-05-08', 'dispFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of grade 3/4 oral mucositis using WHO grading system', 'timeFrame': 'evaluated throughout the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oral mucositis', 'hematologic', 'autologous stem cell transplant', 'velafermin', 'stomatitis', 'oncology - supportive care', 'mouth diseases'], 'conditions': ['Oral Mucositis', 'Stomatitis']}, 'descriptionModule': {'briefSummary': 'CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-16.\n* Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused.\n* ECOG Performance Score of 2 or less\n* Signed Informed Consent Form (ICF)\n\nExclusion Criteria:\n\n* Premenopausal female patients who are pregnant, lactating or are likely to become pregnant\n* Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C\n* Patients with known hypersensitivity to recombinant protein therapeutics\n* Patients who have taken velafermin (CG53135-05) previously\n* Patients who have taken palifermin in the past 90 days\n* Patients who have taken other investigational drugs in the past 30 days\n* Patients who have untreated symptomatic dental infection\n* Patients with a history of sensitivity or allergy to E. coli-derived products\n* Patients with WHO Grade 3 or 4 OM at the time of randomization\n* Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent\n* Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments\n* Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.'}, 'identificationModule': {'nctId': 'NCT00323518', 'briefTitle': 'A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celldex Therapeutics'}, 'officialTitle': 'A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant', 'orgStudyIdInfo': {'id': 'CG53135-CLN-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '30 mcg/kg velafermin', 'interventionNames': ['Drug: velafermin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '10 mcg/kg velafermin', 'interventionNames': ['Drug: velafermin']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '60 mcg/kg velafermin', 'interventionNames': ['Drug: velafermin']}], 'interventions': [{'name': 'velafermin', 'type': 'DRUG', 'otherNames': ['CG53135-05'], 'description': 'administered intravenously as 100mL single dose over 15 minutes on day 1', 'armGroupLabels': ['2', '3', '4']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'administered intravenously as 100mL single dose over 15 minutes on day 1', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94704', 'city': 'Berkley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates 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{'type': 'SPONSOR'}}}}