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Trial record 1 of 1 for:    NCT03916757
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V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer (GBM)

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ClinicalTrials.gov Identifier: NCT03916757
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Immunitor LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Glioma of Brain Biological: V-Boost Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients who passed eligibility requirement will receive daily dose of V-Boost
Masking: None (Open Label)
Masking Description: This is open label study, no masking is required
Primary Purpose: Treatment
Official Title: Open-label Phase II Trial of the Safety and Efficacy of V-Boost in Patients With Refractory Glioblastoma Multiforme (GBM)
Actual Study Start Date : April 16, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: V-Boost recipients
In this open label study all eligible participants will receive daily tablet of V-Boost
Biological: V-Boost
Open label setting
Other Name: V-Boost Immunitor




Primary Outcome Measures :
  1. Effect on tumor size [ Time Frame: 3 months ]
    Imaging of brain at 3-month time post-therapy and comparison to baseline records


Secondary Outcome Measures :
  1. Effect on progression-free survival [ Time Frame: 3 months ]
    Evaluation of patients status on progression free survival



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of GBM
  • ≥ 5 years of age
  • Consent from parents or legal guardian if under-aged

Exclusion Criteria:

  • Severe pulmonary, cardiac or other systemic disease
  • Presence of an acute infection requiring active treatment with antibiotics/antivirals
  • Receiving corticosteroids (e.g., dexamethasone) during study duration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916757


Contacts
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Contact: Aldar Bourinbaiar, MD/PhD +97695130306 immunitor@gmail.com
Contact: Galyna Kutsyna, MD +97695130306 kutsynagalyna@yahoo.com

Locations
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Mongolia
Immunitor LLC Recruiting
Ulaanbaatar, Mongolia
Contact: Aldar Bourinbaiar, MD    97695130306    aldar@immunitor.com   
Contact: Aldar Bourinbayar, MD    +97695130306 ext Bourinbayar    immunitor@yahoo.com   
Principal Investigator: Aldar Bourinbaiar, MD         
Sponsors and Collaborators
Immunitor LLC
Investigators
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Study Chair: Aldar Bourinbayar, MD/PhD Immunitor LLC

Additional Information:
Publications:
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Responsible Party: Immunitor LLC
ClinicalTrials.gov Identifier: NCT03916757     History of Changes
Other Study ID Numbers: Imm008
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Immunitor LLC:
Brain cancer

Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue