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.]

NCT02663271 : TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma
PhasePhase 2
AgesMin: 22 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histologically confirmed GBM, WHO grade IV. GBM variants and secondary GBM are allowed
in any recurrence (including multiple) and have been treated with radiation and
chemotherapy.

- Unequivocal evidence of tumor progression during prior bevacizumab treatment per RANO
criteria.

- Patient is a candidate for, and agrees to proceed with additional bevacizumab
treatment.

- 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 test
within 14 days of treatment.

- Participants of childbearing/reproductive potential must use effective contraception.

- Participants must be able to understand and willing to comply with protocol
requirements as assessed by the investigator.

- Signed informed consent according to institutional guidelines prior to registration.

Exclusion Criteria:

- Inability to undergo brain MRI due to medical or personal reasons.

- Currently receiving investigational agents that are intended as treatments of
recurrent GBM.

- Skull defect such as missing bone or bullet fragments.

- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive
heart failure, unstable angina pectoris, heart attack within the previous 12 months,
stroke (except for TIA) within the previous 6 months, or psychiatric illness/social
situations 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, vagus
nerve stimulator, and other implanted electronic devices in the brain or the spinal
cord.

- Tumor located entirely in the infratentorium.

- History of hypersensitivity to hydrogel.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02663271      |      Link to official Clinicaltrials.gov listing
Locations
Gainesville, Florida
Facility: University of Florida
Investigator: David D Tran, MD, PhD
Contact: Sarah Andrews, RN Phone: 352-273-7891
Click HERE to send email to this center

Saint Louis, Missouri
Facility: Washington University
Investigator: George Ansstas, M.D.
Contact: Grayson Talcott, BS Phone: 314-273-0656
Click HERE to send email to this center




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