NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma

Withdrawn before enrolling · Not applicable

Conditions studied: Anaplastic Oligodendroglioma, Oligoastrocytoma, Oligodendroglioma

In brief

This pilot clinical trial studies the side effects of NovoTTF-200A device in treating patients with newly diagnosed high risk oligodendroglioma. NovoTTF-200A device is a portable battery operated device which produces tumor treating (TT)Fields in the body by means of surface electrodes placed on the skin. TTFields are very low intensity, intermediate frequency electric fields that may slow the growth of tumor cells in patients with high risk oligodendroglioma.

Key facts

Study ID

NCT03353896

Run by

University of Southern California

People needed

0

Starts

2017-12-15

Expected to finish

2020-12-08

Last updated by the study team

2020-12-10

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed oligodendroglioma (oligo) (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification
• Surgically sub-total or unresectable tumors, i.e. in insula, including but not limited to the insula and received standard of care (SOC) radiation
• Historical pathological tissue evidence of high risk oligo (low grade oligo, low grade mixed oligoastrocytoma, anaplastic oligo, anaplastic mixed oligo) by histology and or molecular classification
• 1p and 19q deletion status known
• IDH 1 \& 2 mutations status known
• MGMT status known
• Karnofsky equal or greater than 70
• Life expectancy at least 3 months
• Participants of childbearing age must use effective contraception
• A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if…

• Actively participating in another clinical treatment trial
• Tumor progression after radiation
• Pregnant
• Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
• Documented clinically significant cardiac arrhythmias
• Infra-tentorial tumor

Where it is running

• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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