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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223103
Recruitment Status : Active, not recruiting
First Posted : July 19, 2017
Last Update Posted : February 10, 2023
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Albert Einstein College of Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Poly-ICLC Device: Tumor Treating Fields Biological: Peptides Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : July 31, 2020
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mutation-derived tumor vaccine
MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields
 Drug: Poly-ICLC
Poly-ICLC 100mcg per peptide per dose
Other Name: Hiltonol®

Device: Tumor Treating Fields
an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM
Other Name: Optune®

Biological: Peptides
synthetic long peptides (SLP) as vaccine substrate
Other Name: Personalized peptides


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. The percent Progression Free Survival (PFS) [ Time Frame: 6 months ]
  3. Overall Survival (OS) Rate [ Time Frame: 1 year ]
  4. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223103


Locations
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United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Sponsors and Collaborators
Albert Einstein College of Medicine
NovoCure Ltd.
Investigators
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Principal Investigator: Adilia Hormigo, MD, PhD Albert Einstein College of Medicine
More Information
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Responsible Party: Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03223103    
Other Study ID Numbers: 2022-13817
16-089 ( Other Identifier: PRMC )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Albert Einstein College of Medicine:
Brain cancer
Glioblastoma
Personalized vaccine
Poly-ICLC (polyinosinic-polycytidylic acid)
Immunotherapy
 Cancer
NovoTTF-200A
Optune
GBM
immunogenicity
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Poly ICLC
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs