NCT03353896

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anaplastic Oligodendroglioma
• Oligoastrocytoma
• Oligodendroglioma

Interventions

Type	Name	Description
DEVICE	Wear novoTTF-200A	Wear novoTTF-200A device
PROCEDURE	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2017-12-15
• Primary completion: 2020-12-08
• Completion: 2020-12-08
• First posted: 2017-11-27
• Last updated: 2020-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study