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

Glioblastoma Clinical Trial

Official title:

Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma (GCO 17-0566)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03223103
• Other study ID #: 2022-13817
• Secondary ID: 16-089
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 1, 2018
• Est. completion date: May 2025

Study information

• Verified date: March 2024
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: May 2025
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	NovoCure Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities (DLT)	Feasibility administration of one vaccine; toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale	42 weeks
Secondary	Toxicity grading using CTCAE scale	Safety will be measured by number of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale	1 year
Secondary	The percent Progression Free Survival (PFS)		6 months
Secondary	Overall Survival (OS) Rate		1 year
Secondary	Overall Response Rate	Overall response as measured by RANO (Response assessment in neuro-oncology) Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease	2 years