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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 OBJECTIVES: I. To estimate the proportion of patients who tolerated 75% of treatment goal at months 6, 12, 24. II. 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. OUTLINE: 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.

Official Title
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Pilot Trial of NovoTTF -200A (TTFields) in Patients With Newly Diagnosed High Risk Oligodendrogliomas

Conditions
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Anaplastic Oligodendroglioma, Oligoastrocytoma, Oligodendroglioma

Intervention / Treatment
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* Device: Wear novoTTF-200A
* Procedure: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (medical device)<br>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<br>* Wear novoTTF-200A device<br>* Other names: Medical Devices;Procedure: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of the NovoTTFields treatment in patients with high risk oligodendroglioma | Number of patients with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.03 | Up to 2 months after treatment |