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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria. 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). If patient lacks capacity to consent, a legally authorized representative is allowed to provide written informed consent. 2. Age ≥ 21 years. 3. Karnofsky Performance Status (KPS) ≥ 60. 4. Subjects' planned upfront treatment to be standard of care treatment 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. 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. Viability 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:

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. 1. Inability to fulfill the requirements of the protocol. 2. Secondary GBM or other gliomas. 3. History of sensitivity to Temozolomide. 4. 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. 5. 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02997423
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Iowa
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Corinne E Griguer, PhD
Principal Investigator Affiliation University of Iowa
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

This Biomarker trial is designed to prospectively evaluate the hypothesis that the overall survival (OS) time of a subject with newly diagnosed primary GBM tumors, treated by standard of care (SOC), is a function of the CcO enzymatic activity in the tumor (OS; time interval from date of first diagnosis to death from any cause, irrespective of post-SOC therapies, assessed up to 24 months from accrual). In particular, tumors with high CcO activity are associated with shorter OS time as compared to tumors with low CcO activity. SOC consists of post-surgical radiation therapy with concurrent Temozolomide followed by up to 12 cycles of adjuvant Temozolomide. Additional outcomes are to study the relation between CcO activity in the GBM tumors and progression free survival times (PFS; time intervals from dates of diagnosis to documented disease progression by MRI or tumor-related death) and, to compare the prognostic abilities of CcO activity to other frequently used biomarkers, namely the methylation status of O6-methylguanine-DNA methyltransferase (MGMT), on OS and PFS. Tumor tissue will be submitted by participating centers for measurements of the CcO/Citrate Synthase (CS), MGMT promoter methylation. The subjects will agree to receive the SOC treatment. The therapeutic option at the time of first recurrence is at the discretion of the treating physician. PFS and OS times will be compared with high vs.#46; low CcO activity and with the MGMT methylation status of the tumor. At the time of death or at 24 months s/p enrollment (whichever comes first), the site PI will complete an exit form documenting the details of enrollees' treatment history and date(s) of any tumor progression.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

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University of Alabama at Birmingham

Birmingham, Alabama, 35294

UC Davis, Sacramento, California

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UC Davis

Sacramento, California, 95817

University of Miami, Miami, Florida

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University of Miami

Miami, Florida, 33136

Northwestern University, Chicago, Illinois

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Northwestern University

Chicago, Illinois, 60208

University of Kansas Medical Center, Kansas City, Kansas

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University of Kansas Medical Center

Kansas City, Kansas, 66160

Massachusetts General Hospital, Boston, Massachusetts

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Massachusetts General Hospital

Boston, Massachusetts, 02114

Washington University Medical School, Saint Louis, Missouri

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Washington University Medical School

Saint Louis, Missouri, 63110

Montefiore Medical Center, Bronx, New York

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Montefiore Medical Center

Bronx, New York, 10467

Columbia University Medical Center, New York, New York

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Columbia University Medical Center

New York, New York, 10032

University of Rochester Medical Center, Rochester, New York

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University of Rochester Medical Center

Rochester, New York, 14642

SUNY Stony Brook, Stony Brook, New York

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SUNY Stony Brook

Stony Brook, New York, 11794

University of Cincinnati, Cincinnati, Ohio

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University of Cincinnati

Cincinnati, Ohio, 45219

Ohio State University, Columbus, Ohio

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Ohio State University

Columbus, Ohio, 43210

Oregon Health & Science University, Portland, Oregon

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Oregon Health & Science University

Portland, Oregon, 97239

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261

Vanderbilt University, Nashville, Tennessee

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Vanderbilt University

Nashville, Tennessee, 37235

University of Texas Southwestern, Dallas, Texas

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Address

University of Texas Southwestern

Dallas, Texas, 75390

University of Utah, Salt Lake City, Utah

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Address

University of Utah

Salt Lake City, Utah, 84112

Swedish Neuroscience Institute, Seattle, Washington

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Address

Swedish Neuroscience Institute

Seattle, Washington, 98122