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

NCT03353896 | Withdrawn DMC FDA Device

• 4 other identifiers: 6B-15-1NCI-2017-02074EF-OLIGO-15P30CA014089
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anaplastic Oligodendroglioma; Oligoastrocytoma; Oligodendroglioma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment (medical device)

EXPERIMENTAL

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; Procedure: Quality-of-Life Assessment

Interventions

Wear novoTTF-200A DEVICE

Wear novoTTF-200A device

Also known as: Medical Devices

Treatment (medical device)

Quality-of-Life Assessment PROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (medical device)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• p 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator
• NovoCure Ltd.: collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Oligodendroglioma; Astrocytoma

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Thomas Chen, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: December 15, 2017
• Primary Completion: December 8, 2020
• Study Completion: December 8, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (1)