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

Immunitor

Status and phase

Unknown

Phase 2

Conditions

Glioblastoma Multiforme

Glioma of Brain

Treatments

Biological: V-Boost

Study type

Interventional

Funder types

Industry

Identifiers

NCT03916757

Imm008

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

5 to 99 years old

Volunteers

No Healthy Volunteers

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