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

Oligodendroglioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03353896
• Other study ID #: 6B-15-1
• Secondary ID: NCI-2017-02074EF
• Status: Withdrawn
• Phase: N/A
• Start date: December 15, 2017
• Est. completion date: December 8, 2020

Study information

• Verified date: December 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 8, 2020
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anaplastic Oligodendroglioma
• Oligoastrocytoma
• Oligodendroglioma

Intervention

Device:
• Wear novoTTF-200A
Wear novoTTF-200A device

Procedure:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI), NovoCure Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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