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

Primary Purpose

Glioblastoma

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Poly-ICLC

Tumor Treating Fields

Peptides

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Brain cancer, Glioblastoma, Personalized vaccine, Poly-ICLC (polyinosinic-polycytidylic acid), Immunotherapy, Cancer, NovoTTF-200A, Optune, GBM, immunogenicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mutation-derived tumor vaccine

Arm Description

MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields

Outcomes

Primary Outcome Measures

Dose-limiting toxicities (DLT)

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

Toxicity grading using CTCAE scale

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)

Overall Survival (OS) Rate

Overall Response Rate

Overall response as measured by RANO (Response assessment in neuro-oncology) Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease

Full Information

NCT ID

NCT03223103

First Posted

July 18, 2017

Last Updated

June 9, 2023

Sponsor

Adilia Hormigo

Collaborators

NovoCure Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03223103

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Adilia Hormigo

Collaborators

NovoCure Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

Brain cancer, Glioblastoma, Personalized vaccine, Poly-ICLC (polyinosinic-polycytidylic acid), Immunotherapy, Cancer, NovoTTF-200A, Optune, GBM, immunogenicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mutation-derived tumor vaccine

Arm Type

Experimental

Arm Description

MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields

Intervention Type

Drug

Intervention Name(s)

Poly-ICLC

Other Intervention Name(s)

Hiltonol®

Intervention Description

Poly-ICLC 100mcg per peptide per dose

Intervention Type

Device

Intervention Name(s)

Tumor Treating Fields

Other Intervention Name(s)

Optune®

Intervention Description

an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM

Intervention Type

Biological

Intervention Name(s)

Peptides

Other Intervention Name(s)

Personalized peptides

Intervention Description

synthetic long peptides (SLP) as vaccine substrate

Primary Outcome Measure Information:

Title

Dose-limiting toxicities (DLT)

Description

Time Frame

42 weeks

Secondary Outcome Measure Information:

Title

Toxicity grading using CTCAE scale

Description

Time Frame

1 year

Title

The percent Progression Free Survival (PFS)

Time Frame

6 months

Title

Overall Survival (OS) Rate

Time Frame

1 year

Title

Overall Response Rate

Description

Overall response as measured by RANO (Response assessment in neuro-oncology) Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adilia Hormigo, MD, PhD

Organizational Affiliation

Albert Einstein College of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Albert Einstein College of Medicine

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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