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

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ClinicalTrials.gov Identifier: NCT03223103
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Adilia Hormigo, Icahn School of Medicine at Mount Sinai

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 22, 2019
Estimated Study Completion Date : May 22, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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)].

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


Contacts
Contact: Adilia Hormigo, MD, PhD 212-824-8579 Adilia.hormigo@mssm.edu

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Angela Stangarone, MPH    212-824-8579    angela.stangarone@mssm.edu   
Principal Investigator: Adilia Hormigo, MD, PhD         
Sponsors and Collaborators
Adilia Hormigo
NovoCure Ltd.
Investigators
Principal Investigator: Adilia Hormigo, MD, PhD Icahn School of Medicine at Mount Sinai

Responsible Party: Adilia Hormigo, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03223103     History of Changes
Other Study ID Numbers: GCO 17-0566
16-089 ( Other Identifier: PRMC )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Adilia Hormigo, Icahn School of Medicine at Mount Sinai:
Brain cancer
Glioblastoma
Personalized vaccine
Poly-ICLC
Immunotherapy
Cancer
NovoTTF-200A
Optune
GBM
immunogenicity

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Vaccines
Poly ICLC
Poly I-C
Carboxymethylcellulose Sodium
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers
Laxatives
Gastrointestinal Agents
Antiviral Agents
Anti-Infective Agents