Clinical Trial Details
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NCT02997423 : Cytochrome C Oxidase Activity in Newly Diagnosed Glioblastoma Multiforme (GBM)
AgesMin: 21 Years Max: N/A
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).

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

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. 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

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:      |      Link to official listing
Birmingham, Alabama
Facility: University of Alabama at Birmingham
Contact: James Markert Phone: 205-975-6985
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Sacramento, California
Facility: UC Davis
Contact: Robert O'Donnell Phone: 916-734-5959
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Miami, Florida
Facility: University of Miami
Contact: Macarena de la Fuente Phone: 305-243-2858
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Chicago, Illinois
Facility: Northwestern University
Contact: Priya Kumthekar Phone: 312-503-1818
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Kansas City, Kansas
Facility: University of Kansas Medical Center
Contact: Michael Salacz Phone: 913-574-2650
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Boston, Massachusetts
Facility: Massachusetts General Hospital
Contact: Elizabeth Gerstner Phone: 617-724-2887
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Saint Louis, Missouri
Facility: Washington University Medical School
Contact: Milan Chheda, MD Phone: 314-747-8420
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Bronx, New York
Facility: Montefiore Medical Center
Contact: Fatema Malbari Phone: 718-920-4378
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New York, New York
Facility: Columbia University Medical Center
Contact: Teri Kreisl Phone: 212-342-0571
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Rochester, New York
Facility: University of Rodchester Medical Center
Contact: Nimish Mohile Phone: 585-276-3971
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Stony Brook, New York
Facility: SUNY Stony Brook
Contact: Agnes Kowalska Phone: 631-444-7543
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Cincinnati, Ohio
Facility: University of Cincinnati
Contact: Rekha Chaudhary Phone: 513-558-2119
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Columbus, Ohio
Facility: Ohio State University
Contact: Vinay Puduvalli Phone: 614-685-8324
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Portland, Oregon
Facility: Oregon Health & Science University
Contact: Aclan Dogan Phone: 503-494-8211
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Pittsburgh, Pennsylvania
Facility: University of Pittsburgh Medical Center
Contact: Jan Drappatz Phone: 412-692-2600
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Nashville, Tennessee
Facility: Vanderbilt University
Contact: Stephen Wesley Clark Phone: 615-936-0211
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Dallas, Texas
Facility: University of Texas Southwestern
Contact: Toral Patel Phone: 214-648-3143
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Salt Lake City, Utah
Facility: University of Utah
Contact: Howard Colman Phone: 801-587-4024
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Seattle, Washington
Facility: Swedish Neuroscience Institute
Contact: Jerome Graber Phone: 206-320-2300
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