HUMC 1612: Optune NovoTTF-200A System

NCT03128047 | Completed Phase 1 Results DMC FDA Device

• 1 other identifier: Pro2016-0583
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

High Grade Glioma; Ependymoma

Keywords

pediatric cancer; brain tumor; glioblastoma; high grade brain tumor; malignant brain tumor; recurrent brain tumor

Outcome Measures

Primary Outcomes (2)

• Safety of the Optune NovoTTF-200A System When Used Alone in Pediatric Patients With Recurrent High-grade Gliomas.

  Number of participants receiving treatment with the Optune NovoTTF-200A System with treatment-related adverse events as assessed by CTCAE v4.0.

  56 Days

• Tolerability of the Optune NovoTTF-200A System When Used Alone in Pediatric Patients With Recurrent High-grade Gliomas.

  Number of participants receiving treatment with the Optune NovoTTF-200A System with who return tolerability questionnaire and found the device tolerable

  56 Days

Secondary Outcomes (2)

• 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.

  Up to 2 years after study entry

• 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.

  Up to 2 years after study entry

Study Arms (1)

Recurrent high grade gliomas and ependymomas

EXPERIMENTAL

Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

Device: Optune NovoTTF-200A System

Interventions

Optune NovoTTF-200A System DEVICE

Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.

Recurrent high grade gliomas and ependymomas

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must have a minimum head circumference of 44 cm
• Patients must have a histologically- or cytologically-confirmed supratentorial high-grade glioma or supratentorial ependemoma.
• Patients with metastatic disease involving the infratentorium or spinal cord are eligible providing that they have a supratentorial tumor that is able to be targeted with TTFields.
• Eligible pathologic diagnoses include:
• High-grade Glioma (WHO Grade III or IV): Anaplastic Astrocytoma, Astroblastoma, Diffuse Midline Glioma, Glioblastoma, Gliosarcoma Ependymoma (WHO Grade II or III):Ependymoma, Anaplastic Ependymoma
• Patients with high-grade glioma must must have be newly-diagnosed or have a tumor that is progressive or recurrent following standard treatment. Patients with ependymoma must have a tumor that is progressive or recurrent following standard treatment.
• Patients must have received the maximal feasible resection of their tumor and radiation therapy (unless contraindicated due to patient age) as part of their initial treatment prior to study enrollment.
• Patients must be enrolled before treatment begins. Treatment must start within 14 days of study enrollment.
• All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated in the eligibility section.
• Newly-diagnosed patients must begin therapy within six weeks of the completion of radiotherapy, or within six weeks of surgical resection if radiotherapy is contraindicated.
• Recurrent high-grade glioma patients must begin therapy within four weeks of documented tumor progression by MRI scan.
• Patients must have a Lansky or Karnofsky performance status score of ≥ 50%, corresponding to ECOG categories of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
• Able to undergo adequate tumor imaging, via magnetic resonance imaging (MRI) scan to evaluate disease evolution.
• Adequate hematologic, renal, liver function as demonstrated by laboratory values: ANC ≥ 1,000/ul Hemoglobin ≥8.0 gm/dl Platelet count ≥ 100,000/ul
• Adequate Liver Function Defined As:

You may not qualify if:

• Age less than 5 or greater than or equal to 18 years
• Head circumference \< 44 cm
• Absence of supratentorial tumor
• Use of any other investigational drug within five half-lives of that drug prior to the initiation of protocol therapy
• Anti-cancer therapy within 4 weeks prior to the initiation of protocol therapy (6 weeks for mitomycin and nitrosureas, 4 weeks for curative-intent radiotherapy, and 2 weeks for palliative radiotherapy)
• Any National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE version 4.0) \>Grade 1 toxicities from prior chemotherapy or radiotherapy that could impact on safety outcome assessment
• Any surgery within 14 days prior to initiation of protocol therapy (excluding shunt or line insertion)
• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• Evidence of increased intracranial pressure (midline shift \> 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness) Patients receiving escalating doses of corticosteroids to control symptoms of increased intracranial pressure (e.g., require a stable or decreasing dose of corticosteroids for at least 7 days prior to enrollment) will also be excluded.
• Known \> Grade 1 intracranial or intratumoral hemorrhage either by CT or MRI scan within the last 1 month. Patients with resolving hemorrhage changes, punctuate hemorrhage or hemosiderin may enter the study
• Pregnant female patients, Pregnancy tests with a negative result must be obtained in all post-menarchal females.
• Lactating females must agree they will not breastfeed a child while on this study.
• Males and females of reproductive potential may not participate unless they agree to use an effective contraceptive method and continue to do so for at least 6 months after the completion of therapy.
• Any serious and/or unstable pre-existing medical, psychiatric or other condition which in the Investigator's opinion could interfere with subject safety, obtaining written informed consent, or compliance with the study protocol
• Known hypersensitivity to temozolomide or bevacizumab

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• NovoCure Ltd.: collaborator

Study Sites (2)

Arnold Palmer Hospital for Children

Orlando, Florida, 32806, United States

Location

Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (4)

• Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.

  PMID: 15126372 BACKGROUND

• Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.

  PMID: 17551011 BACKGROUND

• Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

  PMID: 26670971 BACKGROUND

• Chaudhry A, Benson L, Varshaver M, Farber O, Weinberg U, Kirson E, Palti Y. NovoTTF-100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL system user study. World J Surg Oncol. 2015 Nov 11;13:316. doi: 10.1186/s12957-015-0722-3.

  PMID: 26558989 BACKGROUND

MeSH Terms

Conditions

Glioma; Ependymoma; Neoplasms; Brain Neoplasms; Glioblastoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma

Results Point of Contact

• Title: Jeanette Haugh
• Organization: Hackensack Meridian Health

Jeanette.haugh@hmhn.org

5519963457

Study Officials

• Derek Hanson, MD

  Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: April 25, 2017
• Study Start: April 6, 2017
• Primary Completion: July 8, 2024
• Study Completion: April 5, 2025
• Last Updated: July 8, 2025
• Results First Posted: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)