Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02997423 : Cytochrome C Oxidase Activity in Newly Diagnosed Glioblastoma Multiforme (GBM)
Phase
AgesMin: 21 Years Max: N/A
Eligibility
Inclusion Criteria

Pre-Surgery:

1. 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).

2. Age ? 21years

3. Karnofsky Performance Status (KPS) ? 60.

4. Subjects' planned upfront treatment to be SOC with Radiotherapy and Temozolomide (i.e.
TEMODAR) for histologically confirmed GBM at initial diagnosis

5. 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.

6. 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.

7. No other condition (e.g., psychological or geographical) that would preclude study
compliance.

8. An MRI that is consistent with a primary malignant glioma

Post-Surgery:

9. 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).

10. Availability of tumor tissue representative of GBM > 70 mg, snap-frozen within 30
minutes of resection, 10 minutes or less at room temperature.

11. All subjects must have received maximal safe resection followed by standard radiation
therapy with concomitant Temozolomide taken during the course of radiation therapy.

Exclusion Criteria:

1. Inability to fulfill the requirements of the protocol

2. 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.

3. Secondary GBM or other gliomas.

4. History of sensitivity to Temozolomide.

5. 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.

6. GLIADEL wafers in combination with surgical resection.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02997423      |      Link to official Clinicaltrials.gov listing
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