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|NCT03223103 : Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma|
|Ages||Min: 18 Years Max: N/A|
- 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.
- 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
- (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)].
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03223103
| Link to official Clinicaltrials.gov listing