Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT01123304
Status:
TERMINATED
Last Update Posted:
2014-07-17
First Post:
2010-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'This study has been terminated due to lack of availability of investigational product.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-16', 'studyFirstSubmitDate': '2010-05-12', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of multiple intralesional administration of MORAb-028', 'timeFrame': 'Day 33', 'description': 'After each patient completes study treatment the patient is evaluated for dose limiting toxicities (DLTs) up to 1 week after their last dose (at day 33)'}], 'secondaryOutcomes': [{'measure': 'Maximum tolerated dose of intralesional administration of MORAb-028', 'timeFrame': '22 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['melanoma'], 'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'This research is being done to find out the safety of MORAb-028 in subjects with metastatic melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed AJCC Stage IIIB, IIIC or IV melanoma with injectable metastases (in transit, intradermal, or subcutaneous nodules)\n* Tumor accessible to intra-tumoral injections\n* Cumulative tumor volume great enough to accept MORAb-028 injections for a given dose level, based on intent to inject at a concentration of 1 mg/cm3\n\nExclusion Criteria:\n\n* Are candidates for curative surgical excision or lymphadenectomy\n* Prior non-surgical treatment within 4 weeks\n* Known central nervous system (CNS) tumor involvement or metastases\n* Hypersensitivity to MORAb-028'}, 'identificationModule': {'nctId': 'NCT01123304', 'briefTitle': 'Safety Study of Human IgM (MORAb-028) to Treat Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Morphotek'}, 'officialTitle': 'A Phase 1 Clinical Trial of Intra-Tumoral Injection of Human IgM Monoclonal Antibody (MORAb-028) to the Ganglioside GD2 in Subjects With Injectable Metastatic Melanoma', 'orgStudyIdInfo': {'id': 'MORAb028-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MORAb 028', 'interventionNames': ['Drug: MORAb028']}], 'interventions': [{'name': 'MORAb028', 'type': 'DRUG', 'description': '1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.', 'armGroupLabels': ['MORAb 028']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'John Wayne Cancer Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Bruce Wallin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Morphotek'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morphotek', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}