Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-02-25 @ 9:45 PM
Study NCT ID:
NCT03916757
Status:
UNKNOWN
Last Update Posted:
2019-04-17
First Post:
2019-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'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': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is open label study, no masking is required'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients who passed eligibility requirement will receive daily dose of V-Boost'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on tumor size', 'timeFrame': '3 months', 'description': 'Imaging of brain at 3-month time post-therapy and comparison to baseline records'}], 'secondaryOutcomes': [{'measure': 'Effect on progression-free survival', 'timeFrame': '3 months', 'description': 'Evaluation of patients status on progression free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain cancer'], 'conditions': ['Glioblastoma Multiforme', 'Glioma of Brain']}, 'referencesModule': {'references': [{'pmid': '28443252', 'type': 'BACKGROUND', 'citation': 'Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28443252', 'label': 'link to similar study'}]}, 'descriptionModule': {'briefSummary': "The Phase II study to determine the safety and efficacy of V-Boost in treating a type of brain cancer called Glioblastoma Multiforme (GBM). V-Boost is an immunotherapy in which the patient's immune system will be modulated to eliminate tumor cells. V-Boost is made as an oral tablet which contains specially formulated hydrolyzed GBM antigens along with alloantigens. Patients are either newly diagnosed or with recurrent form of GBM who may have been subjected to surgery and/or chemo- or radiation therapy that ended up unsuccessful. The goal is to eradicate GBM tumor cells through daily oral administration of one pill of V-Boost immunotherapeutic vaccine, which so far has not shown any adverse reaction.", 'detailedDescription': 'The proposed Phase II trial is an-open label study of the safety and efficacy of V-Boost in newly diagnosed or treatment-refractory patients with glioblastoma multiforme (GBM) following unsuccesfull resection and/or chemoradiation. The Phase I clinical tria,l carried out in a small, open-label study, demonstrated safety and promising efficacy. The purpose of this study is to gain additional information from a larger clinical trial aimed to recruit at least 20 patients with GBM. Patients may be newly diagnosed with GBM or are those who have been subjected to resection and/or chemotherapy or radiation, but without success. Patients need to have imaging records and health assessment prior to study enrollment. Those on chemotherapy or radiation can be in washout period or may receive immunotherapy concurrently. Patients will be administered daily dose of V-Boost oral tablet for at least one month and additional dosing can be envisaged depending on outcome of first month. The primary objective is to evaluate the effect on tumor size and progression free survival (PFS) in comparison to patients on standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of GBM\n* ≥ 5 years of age\n* Consent from parents or legal guardian if under-aged\n\nExclusion Criteria:\n\n* Severe pulmonary, cardiac or other systemic disease\n* Presence of an acute infection requiring active treatment with antibiotics/antivirals\n* Receiving corticosteroids (e.g., dexamethasone) during study duration'}, 'identificationModule': {'nctId': 'NCT03916757', 'acronym': 'GBM', 'briefTitle': 'V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunitor LLC'}, 'officialTitle': 'Open-label Phase II Trial of the Safety and Efficacy of V-Boost in Patients With Refractory Glioblastoma Multiforme (GBM)', 'orgStudyIdInfo': {'id': 'Imm008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V-Boost recipients', 'description': 'In this open label study all eligible participants will receive daily tablet of V-Boost', 'interventionNames': ['Biological: V-Boost']}], 'interventions': [{'name': 'V-Boost', 'type': 'BIOLOGICAL', 'otherNames': ['V-Boost Immunitor'], 'description': 'Open label setting', 'armGroupLabels': ['V-Boost recipients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulaanbaatar', 'status': 'RECRUITING', 'country': 'Mongolia', 'contacts': [{'name': 'Aldar Bourinbaiar, MD', 'role': 'CONTACT', 'email': 'aldar@immunitor.com', 'phone': '97695130306'}, {'name': 'Aldar Bourinbayar, MD', 'role': 'CONTACT', 'email': 'immunitor@yahoo.com', 'phone': '+97695130306', 'phoneExt': 'Bourinbayar'}, {'name': 'Aldar Bourinbaiar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Immunitor LLC', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}], 'centralContacts': [{'name': 'Aldar Bourinbaiar, MD/PhD', 'role': 'CONTACT', 'email': 'immunitor@gmail.com', 'phone': '+97695130306'}, {'name': 'Galyna Kutsyna, MD', 'role': 'CONTACT', 'email': 'kutsynagalyna@yahoo.com', 'phone': '+97695130306'}], 'overallOfficials': [{'name': 'Aldar Bourinbayar, MD/PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Immunitor LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunitor LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}