Cytochrome C Oxidase Activity in Newly Diagnosed Glioblastoma Multiforme (GBM)
Prospective Phase II Study of Cytochrome C Oxidase Activity as a Novel Biomarker In Subjects With Newly Diagnosed Primary Glioblastoma Multiforme
2 other identifiers
observational
153
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2016
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2016
CompletedFirst Submitted
Initial submission to the registry
December 9, 2016
CompletedFirst Posted
Study publicly available on registry
December 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFebruary 13, 2023
February 1, 2023
6 years
December 9, 2016
February 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
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 is defined as the time interval from date of first diagnosis to death from any cause, irrespective of post-SOC therapies, assessed up to 24 months from accrual.
Date of diagnosis through 24 months after enrollment
Other Outcomes (2)
Progression Free Survival (PFS)
Date of diagnosis through 48 months after enrollment
MGMT methylation status on OS and PFS
Date of diagnosis through 24 months after enrollment
Eligibility Criteria
Newly diagnosed primary Glioblastoma multiforme (GBM) patients who will receive standard of care treatment.
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:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Iowalead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- NeuroNEXT Networkcollaborator
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UC Davis
Sacramento, California, 95817, United States
University of Miami
Miami, Florida, 33136, United States
Northwestern University
Chicago, Illinois, 60208, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Stony Brook
Stony Brook, New York, 11794, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
Vanderbilt University
Nashville, Tennessee, 37235, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
Related Publications (3)
Vogelbaum MA, Jost S, Aghi MK, Heimberger AB, Sampson JH, Wen PY, Macdonald DR, Van den Bent MJ, Chang SM. Application of novel response/progression measures for surgically delivered therapies for gliomas: Response Assessment in Neuro-Oncology (RANO) Working Group. Neurosurgery. 2012 Jan;70(1):234-43; discussion 243-4. doi: 10.1227/NEU.0b013e318223f5a7.
PMID: 21593697BACKGROUNDGalanis E, Wu W, Cloughesy T, Lamborn K, Mann B, Wen PY, Reardon DA, Wick W, Macdonald D, Armstrong TS, Weller M, Vogelbaum M, Colman H, Sargent DJ, van den Bent MJ, Gilbert M, Chang S. Phase 2 trial design in neuro-oncology revisited: a report from the RANO group. Lancet Oncol. 2012 May;13(5):e196-204. doi: 10.1016/S1470-2045(11)70406-5.
PMID: 22554547BACKGROUNDGriguer CE, Oliva CR, Coffey CS, Cudkowicz ME, Conwit RA, Gudjonsdottir AL, Ecklund DJ, Fedler JK, Neill-Hudson TM, Nabors LB, Benge M, Hackney JR, Chase M, Leonard TP, Patel T, Colman H, de la Fuente M, Chaudhary R, Marder K, Kreisl T, Mohile N, Chheda MG, McNeill K, Kumthekar P, Dogan A, Drappatz J, Puduvalli V, Kowalska A, Graber J, Gerstner E, Clark S, Salacz M, Markert J. Prospective biomarker study in newly diagnosed glioblastoma: Cyto-C clinical trial. Neurooncol Adv. 2021 Dec 24;4(1):vdab186. doi: 10.1093/noajnl/vdab186. eCollection 2022 Jan-Dec.
PMID: 35088051RESULT
Biospecimen
Tumor tissue and DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corinne E Griguer, PhD
University of Iowa
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 9, 2016
First Posted
December 20, 2016
Study Start
November 30, 2016
Primary Completion
November 30, 2022
Study Completion
November 30, 2022
Last Updated
February 13, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Upon request.
- Access Criteria
- Written request to principal investigator.
The requestor must submit a formal written request for data sharing, and the request must be approved by the NeuroNEXT Steering Committee and the Publication Committee before any data are shared. Prior to data sharing, the DCC and the external source must also execute a data sharing agreement that includes a description of the data that are requested and how the data will be shared. A contract / usage agreement may be required. The DCC will submit de-identified datasets and associated documentation to NINDS for archiving and public access, consistent with the current NINDS Data Sharing policy. The DCC will provide documentation with each final dataset to ensure that other users can efficiently and accurately use the dataset, and to prevent misinterpretation or misuse. This documentation may include information about how the data were collected, provide details about the code used to generate the dataset, and define variables and variable field locations.