V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer

NCT ID: NCT03916757

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2020-06-15

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.

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.

Conditions

Glioblastoma Multiforme; Glioma of Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

V-Boost recipients

In this open label study all eligible participants will receive daily tablet of V-Boost

Group Type: EXPERIMENTAL

V-Boost

Intervention Type: BIOLOGICAL

Open label setting

Interventions

V-Boost

Open label setting

Intervention Type: BIOLOGICAL

Other Intervention Names

V-Boost Immunitor

Eligibility 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunitor LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldar Bourinbayar, MD/PhD

Role: STUDY_CHAIR

Immunitor LLC

Locations

Immunitor LLC

Ulaanbaatar, , Mongolia

Site Status: RECRUITING

Countries

Mongolia

Central Contacts

Aldar Bourinbaiar, MD/PhD

Role: CONTACT

immunitor@gmail.com

+97695130306

Galyna Kutsyna, MD

Role: CONTACT

kutsynagalyna@yahoo.com

+97695130306

Facility Contacts

Aldar Bourinbaiar, MD

Role: primary

aldar@immunitor.com

97695130306

Aldar Bourinbayar, MD

Role: backup

immunitor@yahoo.com

+97695130306 ext. Bourinbayar

References

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.

Reference Type: BACKGROUND

PMID: 28443252 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/28443252

link to similar study

Other Identifiers

Imm008

Identifier Type: -

Identifier Source: org_study_id