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

Completed

Conditions studied: Glioblastoma

In brief

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.

Key facts

Study ID

NCT02997423

Run by

University of Iowa

People needed

153

Starts

2016-11-30

Expected to finish

2022-11-30

Last updated by the study team

2023-02-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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). If patient lacks capacity to consent, a legally authorized representative is allowed to provide written informed consent.
• Age ≥ 21 years
• Karnofsky Performance Status (KPS) ≥ 60.
• Subjects' planned upfront treatment to be standard of care treatment 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).
• Viability 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.

You may not qualify if…

• Exclusion criteria are proposed that will exclude subjects with pre-existing co-morbidities that could contribute to pre-mature death (e.g., significant cardiovascular history), with non-included pretreated tumors occupying either intracranial and extra-axial space, significantly impaired neurological performance status (e.g., KPS>60), with glial tumors that are genomically distinct from primary GBM tumors (e.g., gliomas arising from a previously diagnosed lower grade than GBM) or those unable to complete the fundamental requirements of the study.
• Inability to fulfill the requirements of the protocol
• 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.
• 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.
• Note: Use of Gliadel wafers, in combination with surgical resection, is allowed if the patient is to follow standard-of-care treatment post-operatively (i.e., radiation therapy with temozolomide). Use of Gliadel wafers during surgery with only radiation therapy post-operatively is excluded (i.e., omitting temozolomide).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UC Davis — Sacramento, California, United States
• University of Miami — Miami, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Washington University Medical School — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• SUNY Stony Brook — Stony Brook, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Swedish Neuroscience Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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