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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03223103
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
NovoCure Ltd.
Information provided by (Responsible Party):
Adilia Hormigo, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE July 18, 2017
First Posted Date  ICMJE July 19, 2017
Last Update Posted Date May 29, 2019
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03223103 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
Official Title  ICMJE Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 22, 2021
Estimated Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)].
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adilia Hormigo, MD, PhD 212-824-8579 Adilia.hormigo@mssm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03223103
Other Study ID Numbers  ICMJE GCO 17-0566
16-089 ( Other Identifier: PRMC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Adilia Hormigo, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Adilia Hormigo
Collaborators  ICMJE NovoCure Ltd.
Investigators  ICMJE
Principal Investigator: Adilia Hormigo, MD, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2019

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