21 to 100 years old
Brain cancer, cancer
Sample of tumor tissue removed during your surgery. Small research samples will be taken during surgery and frozen.
We will not use this sample for research until all of the usual diagnostic studies are completed.
Obtain information on your health, medications, brain scans (MRIs) and progress so that we can compare information we obtain from your tumor tissue with how you are doing.
Willingness and ability to provide written informed consent and to comply with the study protocol as judged by Physician interview (NOTE: This could be patient's Neurosurgeon, Neuro-Oncologist or Study Investigator).
Age ≥ 21years
Karnofsky Performance Status (KPS) ≥ 60.
Subjects' planned upfront treatment to be SOC with Radiotherapy and Temozolomide (i.e. TEMODAR) for histologically confirmed GBM at initial diagnosis
No history of other malignancies except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years.
No serious active infection (e.g., wound infection requiring parenteral antibiotics) or other serious underlying medical conditions that in the opinion of the investigator would compromise standard of care treatment.
No other condition (e.g., psychological or geographical) that would preclude study compliance.
An MRI that is consistent with a primary malignant glioma
Histologically confirmed newly diagnosed Primary GBM before treatment using World Health Organization (WHO) classification criteria (A local pathology report constitutes adequate documentation of histology for initial study enrollment, however central pathology review will be required to confirm the diagnosis of GBM for final data analysis).
Availability of tumor tissue representative of GBM > 70 mg, snap-frozen within 30 minutes of resection, 10 minutes or less at room temperature.
All subjects must have received maximal safe resection followed by standard radiation therapy with concomitant Temozolomide taken during the course of radiation therapy.
Inability to fulfill the requirements of the protocol
Any severe post-operative infection or other complications that may significantly delay the initiation of brain tumor therapy, or other conditions that, in the opinion of the investigator, would compromise the subject's ability to participate in the study.
Secondary GBM or other gliomas.
History of sensitivity to Temozolomide.
Planned upfront treatment with any anti-angiogenic agent targeting the (vascular endothelial growth factor (VEGF) pathway including but not limited to bevacizumab, cediranib, vandetanib, sunitinib, pazopanib, aflibercept, or sorafenib or any immunotherapy regimen.
GLIADEL wafers in combination with surgical resection.
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