NovoTTF-200A Device in Treating Patients With Newly Diagnosed High Risk Oligodendroglioma
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.
|Condition or Disease||Intervention/Treatment||Phase|
- To describe the safety and tolerability of the TTFields treatment in patients with newly diagnosed high risk oligodendroglioma following standard of care treatment.
To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24.
To estimate the progression free survival time. III. To assess quality of life. IV. To assess whether or not there is a correlation between genomics and the efficacy of the TTFields treatment.
Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours daily (QD). Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 months and then monthly thereafter.
Arms and Interventions
|Experimental: Treatment (medical device)|
Beginning 4-8 weeks after standard of care treatment, patients wear NovoTTF-200A device over 18 hours QD. Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
Device: Wear novoTTF-200A
Wear novoTTF-200A device
Procedure: Quality-of-Life Assessment
Primary Outcome Measures
- Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma [Up to 2 months after treatment]
Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.03
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
Actively participating in another clinical treatment trial
Tumor progression after radiation
Has implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain
Documented clinically significant cardiac arrhythmias
Contacts and Locations
|1||USC / Norris Comprehensive Cancer Center||Los Angeles||California||United States||90033|
Sponsors and Collaborators
- University of Southern California
- National Cancer Institute (NCI)
- NovoCure Ltd.
- Principal Investigator: Thomas Chen, MD, University of Southern California
Study Documents (Full-Text)None provided.