The purpose of this study is to use precision medicine in the form of a vaccine, a mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields). The study is designed to determine whether this treatment combination is well tolerated and safe.
This is a single-arm, single institution phase 1a / 1b study to test the safety, tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is prepared in the laboratory with several peptides based on each patient's own tumor sequence. The vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the TTFields.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Poly-ICLC 100mcg per peptide per dose
an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM
synthetic long peptides (SLP) as vaccine substrate
Albert Einstein College of Medicine
The Bronx, New York, United States
Dose-limiting toxicities (DLT)
Safety and Tolerability of the personalized treatment regimen will be assessed in tandem using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. NCI-CTCAE is a standard system for grading and reporting adverse events (AEs) in cancer clinical trials to document the occurrence and severity of AEs, with grades ranging from 1 (mild) to 5 (death). DLTs will be summarized and reported.
Time frame: long term, up to 10 years after treatment initiation
Feasibility of Personalized MTA vaccine administration
Feasibility of the personalized MTA vaccine will be defined as the successful administration of at least one (1) dose to subjects following tissue sample acquisition and will be expressed as the proportion or percentage subjects enrolled in the study who have successfully been administered at least one dose of the personalized MTA vaccine.
Time frame: Up to 42 weeks after treatment initiation
Progression Free Survival (PFS)
PFS will be determined by the percentage of patients whose disease remains stable, without disease progression or death, from the time diagnosis until 6 months after diagnosis.
Time frame: 6 months after diagnosis
Overall Survival (OS)
Overall Survival will be determined by from the time of diagnosis to the time of death, or up to 10 years. OS will be summarized as the percentage of patients who reach the 1-year, 2-year, 5-year, and 10-year milestones.
Time frame: 1 year, 2 years, 5 years, and 10 years after diagnosis
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