Clinical Trial Details
Braintumor Website

[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)
PhaseN/A
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: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02997423      |      Link to official Clinicaltrials.gov listing
Locations
Birmingham, Alabama
Facility: University of Alabama at Birmingham
Investigator:
Contact: James Markert Phone: 205-975-6985
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Sacramento, California
Facility: UC Davis
Investigator:
Contact: Robert O'Donnell Phone: 916-734-5959
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Miami, Florida
Facility: University of Miami
Investigator:
Contact: Macarena de la Fuente Phone: 305-243-2858
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Chicago, Illinois
Facility: Northwestern University
Investigator:
Contact: Priya Kumthekar Phone: 312-503-1818
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Kansas City, Kansas
Facility: University of Kansas Medical Center
Investigator:
Contact: Michael Salacz Phone: 913-574-2650
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Boston, Massachusetts
Facility: Massachusetts General Hospital
Investigator:
Contact: Elizabeth Gerstner Phone: 617-724-2887
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Saint Louis, Missouri
Facility: Washington University Medical School
Investigator:
Contact: Milan Chheda, MD Phone: 314-747-8420
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New York, New York
Facility: Columbia University Medical Center
Investigator:
Contact: Teri Kreisl Phone: 212-342-0571
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Rochester, New York
Facility: University of Rodchester Medical Center
Investigator:
Contact: Nimish Mohile Phone: 585-276-3971
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Stony Brook, New York
Facility: SUNY Stony Brook
Investigator:
Contact: Agnes Kowalska Phone: 631-444-7543
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The Bronx, New York
Facility: Montefiore Medical Center
Investigator:
Contact: Fatema Malbari Phone: 718-920-4378
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Cincinnati, Ohio
Facility: University of Cincinnati
Investigator:
Contact: Rekha Chaudhary Phone: 513-558-2119
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Columbus, Ohio
Facility: Ohio State University
Investigator:
Contact: Vinay Puduvalli Phone: 614-685-8324
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Portland, Oregon
Facility: Oregon Health & Science University
Investigator:
Contact: Aclan Dogan Phone: 503-494-8211
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Pittsburgh, Pennsylvania
Facility: University of Pittsburgh Medical Center
Investigator:
Contact: Jan Drappatz Phone: 412-692-2600
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Nashville, Tennessee
Facility: Vanderbilt University
Investigator:
Contact: Stephen Wesley Clark Phone: 615-936-0211
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Dallas, Texas
Facility: University of Texas Southwestern
Investigator:
Contact: Toral Patel Phone: 214-648-3143
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Salt Lake City, Utah
Facility: University of Utah
Investigator:
Contact: Howard Colman Phone: 801-587-4024
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Seattle, Washington
Facility: Swedish Neuroscience Institute
Investigator:
Contact: Jerome Graber Phone: 206-320-2300
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