Clinical Trial Details
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NCT03223103 : Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Age ? 18

- Confirmation of GBM (WHO grade IV).

- Maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide

- 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

- 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)].
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