Cytochrome C Oxidase Activity in Newly Diagnosed Glioblastoma Multiforme (GBM)

This is a multi-institutional, consortium-based, non-interventional prospective blinded
endpoints clinical study to determine whether high activity of Cytochrome C Oxidase (CcO) in
tumor specimens from subjects with newly diagnosed primary GBM is associated with shortened
OS (primary outcome) and PFS (secondary outcome) times.

Eligibility Criteria

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 and be planning to undergo
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.

 

Study Contact

Michael Salacz, msalacz@kumc.edu, 913-574-2650

Estimated Completion Date

Sunday, November 1, 2020

ClinicalTrials.gov #

NCT02997423
04/03/2017