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.
The study is designed to determine whether this treatment combination is well tolerated and safe.
Brief Title
Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
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.
The vaccine is given after the radiation and chemotherapy portion of the treatment, in the maintenance phase of temozolomide in conjunction with the TTFields.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Glioblastoma
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)
* 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)
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Brain cancer
Glioblastoma
Personalized vaccine
Poly-ICLC (polyinosinic-polycytidylic acid)
Immunotherapy
Cancer
NovoTTF-200A
Optune
GBM
immunogenicity
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03223103
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2022-13817
Overall Status
Active, not recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
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)
Primary Outcomes
Outcome Description
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
Outcome Measure
Dose-limiting toxicities (DLT)
Outcome Time Frame
42 weeks
Secondary Ids
Secondary Id
16-089
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
1 year
Outcome Measure
Toxicity grading using CTCAE scale
Outcome Time Frame
6 months
Outcome Measure
The percent Progression Free Survival (PFS)
Outcome Time Frame
1 year
Outcome Measure
Overall Survival (OS) Rate
Outcome Description
Overall response as measured by RANO (Response assessment in neuro-oncology) Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease
Outcome Time Frame
2 years
Outcome Measure
Overall Response Rate
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Adilia Hormigo
Investigator Email
adilia.hormigo@einsteinmed.edu