V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glioblastoma Multiforme, Glioma of Brain

Intervention / Treatment
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* Biological: V-Boost


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All patients who passed eligibility requirement will receive daily dose of V-Boost
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V-Boost recipients<br>In this open label study all eligible participants will receive daily tablet of V-Boost | Biological: V-Boost<br>* Open label setting<br>* Other names: V-Boost Immunitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on tumor size | Imaging of brain at 3-month time post-therapy and comparison to baseline records | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on progression-free survival | Evaluation of patients status on progression free survival | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain cancer