V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer

Last updated: April 15, 2019
Sponsor: Immunitor LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Gliomas

Glioblastoma Multiforme

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT03916757
Imm008
  • Ages 5-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of GBM

  • ≥ 5 years of age

  • Consent from parents or legal guardian if under-aged

Exclusion

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

Total Participants: 20
Study Start date:
April 16, 2019
Estimated Completion Date:
June 15, 2020

Study 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.

Connect with a study center

  • Immunitor LLC

    Ulaanbaatar,
    Mongolia

    Active - Recruiting

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