Last updated: May 31, 2022
Sponsor: University of Florida
Overall Status: Terminated
Phase
2
Condition
Glioblastoma Multiforme
Brain Tumor
Gliomas
Treatment
N/AClinical Study ID
NCT02663271
IRB201600074
OCR14874
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed GBM, WHO grade IV. GBM variants and secondary GBM are allowedin any recurrence (including multiple) and have been treated with radiation andchemotherapy.
- Unequivocal evidence of tumor progression during prior bevacizumab treatment per RANOcriteria.
- Patient is a candidate for, and agrees to proceed with additional bevacizumabtreatment.
- Male or female at least 22 years of age or older.
- Karnofsky Performance Scale (KPS) ≥ 60%.
- Planned treatment with TTFields therapy.
- Women of childbearing potential must have a negative serum or urine pregnancy testwithin 14 days of treatment.
- Participants of childbearing/reproductive potential must use effective contraception.
- Participants must be able to understand and willing to comply with protocolrequirements as assessed by the investigator.
- Signed informed consent according to institutional guidelines prior to registration.
Exclusion
Exclusion Criteria:
- Inability to undergo brain MRI due to medical or personal reasons.
- Currently receiving investigational agents that are intended as treatments ofrecurrent GBM.
- Skull defect such as missing bone or bullet fragments.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestiveheart failure, unstable angina pectoris, heart attack within the previous 12 months,stroke (except for TIA) within the previous 6 months, or psychiatric illness/socialsituations that would limit compliance with study requirements.
- Intracranial hemorrhage except for tumor associated micro hemorrhage.
- Women who are pregnant or breastfeeding.
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, vagusnerve stimulator, and other implanted electronic devices in the brain or the spinalcord.
- Tumor located entirely in the infratentorium.
- History of hypersensitivity to hydrogel.
Study Design
Total Participants: 10
Study Start date:
December 19, 2016
Estimated Completion Date:
June 11, 2021
Study Description
Connect with a study center
University of Florida
Gainesville, Florida 32611
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University
St. Louis, Missouri 63110
United StatesSite Not Available

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