Status:
WITHDRAWN
NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Cancer Institute (NCI)
NovoCure Ltd.
Conditions:
Anaplastic Oligodendroglioma
Oligoastrocytoma
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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 devi...
Detailed Description
PRIMARY OBJECTIVES: I. To describe the safety and tolerability of the TTFields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment. SECONDARY ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03353896
Start Date
December 15 2017
End Date
December 8 2020
Last Update
December 10 2020
Active Locations (1)
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1
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033