V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer
GBM
Open-label Phase II Trial of the Safety and Efficacy of V-Boost in Patients With Refractory Glioblastoma Multiforme (GBM)
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
April 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2020
CompletedApril 17, 2019
April 1, 2019
1 year
April 10, 2019
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect on tumor size
Imaging of brain at 3-month time post-therapy and comparison to baseline records
3 months
Secondary Outcomes (1)
Effect on progression-free survival
3 months
Study Arms (1)
V-Boost recipients
EXPERIMENTALIn this open label study all eligible participants will receive daily tablet of V-Boost
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of GBM
- ≥ 5 years of age
- Consent from parents or legal guardian if under-aged
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immunitor LLClead
Study Sites (1)
Immunitor LLC
Ulaanbaatar, Mongolia
Related 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.
PMID: 28443252BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aldar Bourinbayar, MD/PhD
Immunitor LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- This is open label study, no masking is required
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2019
First Posted
April 16, 2019
Study Start
April 16, 2019
Primary Completion
April 15, 2020
Study Completion
June 15, 2020
Last Updated
April 17, 2019
Record last verified: 2019-04