Clinical Trial Finder

Inclusion Criteria:

• - Age ≥ 18.

• - Confirmation of GBM (WHO grade IV).

• - Maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide (45-70Gy) - Stable disease after treatment of radiation with chemotherapy.

• - Life expectancy > 16 weeks.

• - Performance status of 0-2 (Eastern Cooperative Oncology Group).

• - First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from the last dose of concomitant Temozolomide or radiotherapy.

• - Must have tumor tissue sufficient sequencing.

• - Have adequate bone marrow function.

• - Require Dexamethasone ≤ 4mg daily on a stable dose.

• - Acceptable hematologic, hepatic, and renal function and these tests must be performed within 14 days prior to study.

• - The participant must be deemed competent to give informed consent.

• - The participant must agree to use two effective forms of contraception beginning at least four (4) weeks prior to study entry.

Exclusion Criteria:

• - Progression of disease at time of screening.

• - Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.

• - Infra-tentorial tumor or multifocal disease.

• - History of hypersensitivity reaction to Temozolomide.

• - Receiving any other investigational agents.

• - Prior history of unrelated neoplastic disease, and having received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation.

• - (HIV/AIDS), Chronic hepatitis B or hepatitis C.

• - History of, or is reasonably suspected to meet criteria for the diagnosis of a known congenital or acquired disorder causing systemic immunosuppression.

• - History of, or is reasonably suspected to meet criteria for the diagnosis of a systemic auto-immune/inflammatory disease or other autoimmune disorder with the exception of: Vitiligo.

• - Positive pregnancy test [45 CFR 46.203(b)].

(CFR = Code of Federal Regulations)

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.

Arms

Experimental: Mutation-derived tumor vaccine

MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields

Interventions

Drug: - Poly-ICLC

Poly-ICLC 100mcg per peptide per dose

Device: - Tumor Treating Fields

an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM

Biological: - Peptides

synthetic long peptides (SLP) as vaccine substrate