Clinical trial NCT03223103: Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Glioblastoma
Keywords: Brain cancer
Glioblastoma
Personalized vaccine
Poly-ICLC (polyinosinic-polycytidylic acid)
Immunotherapy
Cancer
NovoTTF-200A
Optune
GBM
immunogenicity
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: NovoCure Ltd.
First posted: 2017-07-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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 \[45 CFR 46.203(b)\]. (CFR = Code of Federal Regulations)

Primary outcomes:
measure: Dose-limiting toxicities (DLT)
timeFrame: 42 weeks
Secondary outcomes:
measure: Toxicity grading using CTCAE scale
timeFrame: 1 year
measure: The percent Progression Free Survival (PFS)
timeFrame: 6 months
measure: Overall Survival (OS) Rate
timeFrame: 1 year
measure: Overall Response Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Adilia Hormigo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: