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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Oligoastrocytoma; Oligodendroglioma; Anaplastic Oligodendroglioma
• Intervention / Treatment: Procedure: Quality-of-Life Assessment; Device: Wear novoTTF-200A

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 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Device: Wear novoTTF-200A; Wear novoTTF-200A device; Other Names: Medical Devices

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI); NovoCure Ltd.
• Investigators: Principal Investigator: Thomas Chen, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2017
• Primary Completion (ACTUAL): December 8, 2020
• Study Completion (ACTUAL): December 8, 2020

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (ACTUAL): November 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Oligodendroglioma
• Other Study ID Numbers: 6B-15-1 (OTHER: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2017-02074 (REGISTRY: CTRP (Clinical Trial Reporting Program)); EF-OLIGO-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes