V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer

Phase 2

• Conditions: Glioblastoma Multiforme; Glioma of Brain
• Interventions: Biological: V-Boost

• Registration Number: NCT03916757
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-15
• Study Start: 2019-04-16
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2020-04-15
• Study Completion: 2020-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Effect on tumor size	3 months	Imaging of brain at 3-month time post-therapy and comparison to baseline records

Secondary Outcome Measures

Name	Time	Method
Effect on progression-free survival	3 months	Evaluation of patients status on progression free survival

Trial Locations

Locations (1)

Immunitor LLC; 🇲🇳 Ulaanbaatar, Mongolia