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

• Status: Active, not recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adilia Hormigo; Adilia M Hormigo
• Collaborator: NovoCure Ltd.
• Treatments: Carboxymethylcellulose Sodium; Poly I-C; Poly ICLC; Vaccines

Criteria

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)].