- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03223103
Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma (GCO 17-0566)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Bronx, New York, United States, 10461
- Albert Einstein College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mutation-derived tumor vaccine
MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields
|
Poly-ICLC 100mcg per peptide per dose
Other Names:
an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM
Other Names:
synthetic long peptides (SLP) as vaccine substrate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicities (DLT)
Time Frame: 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
|
42 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity grading using CTCAE scale
Time Frame: 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
|
1 year
|
The percent Progression Free Survival (PFS)
Time Frame: 6 months
|
6 months
|
|
Overall Survival (OS) Rate
Time Frame: 1 year
|
1 year
|
|
Overall Response Rate
Time Frame: 2 years
|
Overall response as measured by RANO (Response assessment in neuro-oncology) Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adilia Hormigo, MD, PhD, Albert Einstein College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-13817
- 16-089 (Other Identifier: PRMC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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