Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-28 @ 11:45 AM
Study NCT ID:
NCT03033992
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2017-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optune for Children With High-Grade Glioma or Ependymoma, and Optune With Radiation Therapy for Children With DIPG
Sponsor:
Pediatric Brain Tumor Consortium
Organization:
Study Overview
Official Title:
Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma or Ependymoma, and Feasibility and Efficacy Trial of Optune in Conjunction With Radiation Therapy for Children With Newly Diagnosed DIPG
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter trial of the Optune device to examine the feasibility and to describe the device-related toxicity in children with supratentorial high grade glioma (HGG) or ependymoma (Stratum 1) and to examine the feasibility and efficacy of concurrent Optune and standard focal radiation therapy (RT) in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum 2).
Detailed Description:
The primary objectives of Stratum 1 are: 1) to evaluate the feasibility of treatment with Optune in pediatric patients with recurrent/refractory/progressive supratentorial malignant glioma or ependymoma, and 2) to describe the Optune device treatment-related toxicities in children with recurrent/refractory/progressive supratentorial malignant glioma or ependymoma.
The primary objectives of Stratum 2 are: 1) to describe the safety and tolerability of concurrent Optune therapy and RT (Phase I component), 2) to evaluate the feasibility of treatment with concurrent Optune and RT (Phase II component), and 3) to estimate the overall survival (Phase II component) in children and adolescents with newly diagnosed DIPG treated with concurrent Optune therapy and standard RT.
The Optune System produces alternating electrical fields, called tumor treatment fields (TTFields) by means of 4 transducer arrays placed on the shaved scalp. The very low intensity, intermediate frequency electric fields impair the growth of tumor cells through the arrest of cell division and inducing apoptosis. Preclinical studies have demonstrated TTFields synergistically enhance the efficacy of irradiation in glioma cell lines.
Optune will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Treatment may continue up to 26 cycles in Stratum 1 and Optune treatment may continue for up to 5 years in Stratum 2 if the participant is deriving benefit and in the absence of significant treatment-related toxicity. Patients will be followed for 2 years from the cessation of protocol treatment in Stratum 1, and for 3 years from the cessation of Optune device treatment in Stratum 2 for the monitoring of unexpected later developing toxicities and to document disease progression, event-free and overall survival.
For patients in Stratum 1, the therapy will be deemed feasible for patients who are able to use the device for ≥ 18 hours/day for at least 23 days out of 28 days of cycle one (feasibility assessment period). A total of 20 patients need to be assessed with an interim analysis to be conducted after the first 11 patients. Kaplan-Meier estimates of EFS for all eligible patients who use the device for at least 1 day will be provided separately for the two histology-based cohorts i.e. HGG and Ependymoma.
For patients in Stratum 2, the study will consist of two parts: a phase I portion to evaluate the safety and tolerability of concurrent Optune and RT; and a phase II portion to evaluate the feasibility and efficacy of concurrent Optune and standard RT. The therapy will be deemed feasible for patients who are able to use the device for ≥ 18 hours/day for at least 40 of the 49 days of the feasibility assessment period of cycle one, which consists of concurrent Optune and RT. Up to 18 evaluable patients may need to be assessed for the phase I component. A total of 30 patients need to be assessed for the phase II component (6 of whom will be counted from the phase I component). The design also incorporates 2 interim analyses for futility assessed when 9 and 14 events are observed.
The primary objectives of Stratum 2 are: 1) to describe the safety and tolerability of concurrent Optune therapy and RT (Phase I component), 2) to evaluate the feasibility of treatment with concurrent Optune and RT (Phase II component), and 3) to estimate the overall survival (Phase II component) in children and adolescents with newly diagnosed DIPG treated with concurrent Optune therapy and standard RT.
The Optune System produces alternating electrical fields, called tumor treatment fields (TTFields) by means of 4 transducer arrays placed on the shaved scalp. The very low intensity, intermediate frequency electric fields impair the growth of tumor cells through the arrest of cell division and inducing apoptosis. Preclinical studies have demonstrated TTFields synergistically enhance the efficacy of irradiation in glioma cell lines.
Optune will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Treatment may continue up to 26 cycles in Stratum 1 and Optune treatment may continue for up to 5 years in Stratum 2 if the participant is deriving benefit and in the absence of significant treatment-related toxicity. Patients will be followed for 2 years from the cessation of protocol treatment in Stratum 1, and for 3 years from the cessation of Optune device treatment in Stratum 2 for the monitoring of unexpected later developing toxicities and to document disease progression, event-free and overall survival.
For patients in Stratum 1, the therapy will be deemed feasible for patients who are able to use the device for ≥ 18 hours/day for at least 23 days out of 28 days of cycle one (feasibility assessment period). A total of 20 patients need to be assessed with an interim analysis to be conducted after the first 11 patients. Kaplan-Meier estimates of EFS for all eligible patients who use the device for at least 1 day will be provided separately for the two histology-based cohorts i.e. HGG and Ependymoma.
For patients in Stratum 2, the study will consist of two parts: a phase I portion to evaluate the safety and tolerability of concurrent Optune and RT; and a phase II portion to evaluate the feasibility and efficacy of concurrent Optune and standard RT. The therapy will be deemed feasible for patients who are able to use the device for ≥ 18 hours/day for at least 40 of the 49 days of the feasibility assessment period of cycle one, which consists of concurrent Optune and RT. Up to 18 evaluable patients may need to be assessed for the phase I component. A total of 30 patients need to be assessed for the phase II component (6 of whom will be counted from the phase I component). The design also incorporates 2 interim analyses for futility assessed when 9 and 14 events are observed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UM1CA081457 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2016-00926 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| PBTC-048 | OTHER | Pediatric Brain Tumor Consortium | View | |
| PBTC-048 | OTHER | CTEP | View |