V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer (GBM)

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

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Aldar Bourinbaiar, MD/PhD; +97695130306; immunitor@gmail.com

Contact: Galyna Kutsyna, MD; +97695130306; kutsynagalyna@yahoo.com

Locations

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

• Study Chair: Aldar Bourinbayar, MD/PhD; Immunitor LLC

More Information

Additional Information:

link to similar study 

Publications:

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.

• Responsible Party: Immunitor LLC
• ClinicalTrials.gov Identifier: NCT03916757
• Other Study ID Numbers: Imm008
• First Posted: April 16, 2019
• Last Update Posted: April 17, 2019
• Last Verified: April 2019

• 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:

Glioblastoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue