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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 : November 14, 2018
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Adilia Hormigo, Icahn School of Medicine at Mount Sinai

July 18, 2017
July 19, 2017
November 14, 2018
March 1, 2018
May 22, 2019   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03223103 on ClinicalTrials.gov Archive Site
  • 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
  • The percent Progression Free Survival (PFS) [ Time Frame: 6 months ]
  • Overall Survival (OS) Rate [ Time Frame: 1 year ]
  • Overall Response Rate [ Time Frame: 2 years ]
    Overall response as measured by RANO Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glioblastoma
  • 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
Experimental: Mutation-derived tumor vaccine
MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields
Interventions:
  • Drug: Poly-ICLC
  • Device: Tumor Treating Fields
  • Biological: Peptides
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
May 22, 2020
May 22, 2019   (Final data collection date for primary outcome measure)

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)].
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Adilia Hormigo, MD, PhD 212-824-8579 Adilia.hormigo@mssm.edu
United States
 
 
NCT03223103
GCO 17-0566
16-089 ( Other Identifier: PRMC )
No
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
Plan to Share IPD: Undecided
Adilia Hormigo, Icahn School of Medicine at Mount Sinai
Adilia Hormigo
NovoCure Ltd.
Principal Investigator: Adilia Hormigo, MD, PhD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP