Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

Albert Einstein College of Medicine

Status and phase

Active, not recruiting

Phase 1

Conditions

Glioblastoma

Treatments

Biological: Peptides

Drug: Poly-ICLC

Device: Tumor Treating Fields

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03223103

2022-13817

16-089

Details and patient eligibility

About

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.

Full description

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)