NCT03705351

Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

Detailed description

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule. The expected toxicity is skin related, and patients will be followed closely with weekly skin and neurological examinations during radiation therapy and for 8 weeks afterwards to capture any delayed toxicity as they begin adjuvant therapy per routine treatment. As long as study treatment is tolerated and their conditions remain stable, patients will continue the treatment for up to 24 months. Prior to enrollment, an exploratory analysis of radiation dosimetry will be performed by phantom modeling incorporating the Optune arrays. The study incorporates three stages of recruitment to confirm the safety of combining tumor treating fields therapy with concurrent chemoradiation: a safety lead-in cohort of the first 6 patients enrolled, a second safety lead-in cohort of 9 patients, and an expansion cohort with 15 additional patients.

Conditions

• Glioblastoma
• Cancer of Brain
• Glioblastoma Multiforme
• Brain Tumor

Interventions

Type	Name	Description
DEVICE	Tumor Treating Fields	Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.
DRUG	Temozolomide	Patients will be given temozolomide according to routine treatment dosing and schedule.
RADIATION	Radiation Therapy	Patients will be given radiation therapy according to routine treatment dosing and schedule.

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-02-24
• Completion: 2022-02-24
• First posted: 2018-10-15
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study