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Feasibility of Treating High Grade Gliomas in Children with Tumor-Treating Fields: A Case Series.

ABSTRACT: Children diagnosed with high grade gliomas (HGG) have dismal prognoses and treatment options remain limited. Tumor treating fields (TTFields) in combination with temozolomide (TMZ) is approved for the treatment of newly diagnosed and recurrent glioblastoma (GBM) in adult patients. However, clinical experience with TTFields in the pediatric HGG population is lacking. This retrospective review of four clinical cases was undertaken to evaluate the feasibility of treating children diagnosed with HGG off-label with TTFields. Patients were evaluated for device compliance, safety, and outcome. Treatment with TTFields was delivered via four transducer arrays placed on the shaved scalp, which were connected to a portable device generating 200 kHz alternating electric fields. One female and three male patients (ages 4-16 years) with heavily pretreated HGG were treated with TTFields off-label from March 2015 to December 2016. In three of these cases, TTFields were administered in combination with TMZ. Across all four patient cases, average wear compliance rates ranged between 53% and 92%. No device-related toxicities were reported during treatment with TTFields delivered for up to four months. All patients eventually died of the disease. TTFields was well tolerated in our limited cohort of patients. Compliance times were similar to what has been reported in adults without significant toxicity. Further studies of the efficacy and safety of TTFields in children with HGG are underway in a clinical trial setting.

SUBMITTER: Crawford J

PROVIDER: S-EPMC7641478 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Feasibility of Treating High Grade Gliomas in Children with Tumor-Treating Fields: A Case Series.

Crawford John J Saria Marlon G MG Dhall Girish G Margol Ashley A Kesari Santosh S

Cureus 20201005 10

Children diagnosed with high grade gliomas (HGG) have dismal prognoses and treatment options remain limited. Tumor treating fields (TTFields) in combination with temozolomide (TMZ) is approved for the treatment of newly diagnosed and recurrent glioblastoma (GBM) in adult patients. However, clinical experience with TTFields in the pediatric HGG population is lacking. This retrospective review of four clinical cases was undertaken to evaluate the feasibility of treating children diagnosed with HGG ...[more]

PMID: 33163308

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Project description:Abstract BACKGROUND Children with recurrent or progressive pediatric CNS tumors have poor prognoses. Optune delivers TTFields, an anti-mitotic FDA-approved cancer therapy, for adult patients with newly diagnosed and recurrent supratentorial GBM. Methods This multicenter trial [NCT03033992] examines the feasibility and device-related toxicity of TTFields in 20 children aged 5–21 years with recurrent supratentorial HGG and ependymoma. Secondary objectives include: response rate, event-free survival, compliance and QoL. Feasibility in this trial is defined as the ability of pediatric subjects to wear Optune ≥18 hours/day for at least 23/28 days of cycle one following a 7-day learning period. Treatment may continue up to 26 cycles based on observed benefit and safety. QOL instruments include PROMIS and Neuro-QOL. Following enrollment of the 11th evaluable subject, the study will be temporarily suspended to share interim feasibility and safety data with the FDA. RESULTS This planned interim analysis included 11 patients (7 males/4 females) with supratentorial tumors: ten HGG and one ependymoma. Median age was 14.2 (6.4–21.3) years. Ten patients were evaluable (1 Progressive Disease) during the feasibility period) and 4 remained on study through 4 cycles and one patient is currently on Cycle 14. One grade 5 intracranial hemorrhage not associated with the device and no grade IV toxicities occurred, 3 patients had seizures (grade 1–3), fatigue, scalp pain, localized rash, and headache (none greater than grade 3). Of the 10 evaluable patients, 7 satisfied the feasibility criteria for the Optune therapy, which is above the prespecified threshold of at least 6/11. CONCLUSION This is the first prospective safety and feasibility trial for Optune in children with recurrent supratentorial HGG and ependymoma. Preliminary results indicate feasibility with minimal toxicity. Accrual to the study is ongoing. An amendment is in progress adding a stratum for newly diagnosed diffuse intrinsic pontine glioma (DIPG) patients.

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Feasibility of Treating High Grade Gliomas in Children with Tumor-Treating Fields: A Case Series.

Publications

Feasibility of Treating High Grade Gliomas in Children with Tumor-Treating Fields: A Case Series.

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