Adults 5 to 21, any sex, with High Grade Glioma or Ependymoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety of the Optune NovoTTF-200A System When Used Alone in Pediatric Patients With Recurrent High-grade Gliomas.Primary· 56 Days
Number of participants receiving treatment with the Optune NovoTTF-200A System with treatment-related adverse events as assessed by CTCAE v4.0.
Group
Value
95% CI
Recurrent High Grade Gliomas and Ependymomas
0
Tolerability of the Optune NovoTTF-200A System When Used Alone in Pediatric Patients With Recurrent High-grade Gliomas.Primary· 56 Days
Number of participants receiving treatment with the Optune NovoTTF-200A System with who return tolerability questionnaire and found the device tolerable
Group
Value
95% CI
Recurrent High Grade Gliomas and Ependymomas
6
Assess the Progression Free of Patients Treated on This Study Protocol to Aid in the Future Development of Pediatric Phase II/III Studies Using the Optune NovoTTF-200A System.Secondary· Up to 2 years after study entry
Number of patients who are progression-free. Disease progression is defined as 25% or more increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed since the start of treatment (see exception below), OR the appearance of one or more new lesions, OR worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) PLUS any increase in tumor cross-sectional area (or tumor volume).
Group
Value
95% CI
Recurrent High Grade Gliomas and Ependymomas
1
Assess the Overall Survival of Patients Treated on This Study Protocol to Aid in the Future Development of Pediatric Phase II/III Studies Using the Optune NovoTTF-200A System.Secondary· Up to 2 years after study entry
Number of patients who were alive at 2 years post study entry
Group
Value
95% CI
Recurrent High Grade Gliomas and Ependymomas
1
Adverse events — posted to ClinicalTrials.gov
Time frame: For 30 days after participants stopped wearing the device, up to 2 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine if the Optune NovoTTF-200A device can be safely used in combination with chemotherapy in pediatric patients with recurrent high-grade glioma and ependemoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06987708 — Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers
· NA
· not yet recruiting
NCT06575894 — Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation
· NA
· not yet recruiting
NCT07442669 — Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
· NA
· not yet recruiting
NCT06991166 — OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hackensack Meridian Health
Last refreshed: 8 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03128047.