Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
- Conditions
- Glioblastoma
- Interventions
- Registration Number
- NCT03223103
- Lead Sponsor
- Albert Einstein College of Medicine
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 13
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mutation-derived tumor vaccine Tumor Treating Fields MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields Mutation-derived tumor vaccine Peptides MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields Mutation-derived tumor vaccine Poly-ICLC MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields
- Primary Outcome Measures
Name Time Method Dose-limiting toxicities (DLT) 42 weeks 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
- Secondary Outcome Measures
Name Time Method Toxicity grading using CTCAE scale 1 year 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
The percent Progression Free Survival (PFS) 6 months Overall Response Rate 2 years Overall response as measured by RANO (Response assessment in neuro-oncology) Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease
Overall Survival (OS) Rate 1 year
Trial Locations
- Locations (1)
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States