V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer

Glioblastoma Multiforme Clinical Trial

— GBM  

Official title:

Open-label Phase II Trial of the Safety and Efficacy of V-Boost in Patients With Refractory Glioblastoma Multiforme (GBM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03916757
• Other study ID #: Imm008
• Status: Recruiting
• Phase: Phase 2
• Start date: April 16, 2019
• Est. completion date: June 15, 2020

Study information

• Verified date: April 2019
• Source: Immunitor LLC
• Contact: Aldar Bourinbaiar, MD/PhD
• Phone: +97695130306
• Email: immunitor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Glioma of Brain

Intervention

Biological:
• V-Boost
Open label setting

Locations

Country	Name	City	State
Mongolia	Immunitor LLC	Ulaanbaatar

Sponsors (1)

Lead Sponsor	Collaborator
Immunitor LLC

Country where clinical trial is conducted

Mongolia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on tumor size	Imaging of brain at 3-month time post-therapy and comparison to baseline records	3 months
Secondary	Effect on progression-free survival	Evaluation of patients status on progression free survival	3 months

External Links

•   link to similar study