Your session is about to expire
← Back to Search
Device
Optune Device for Brain Cancer
Phase 1
Waitlist Available
Led By Derek Hanson, MD
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after study entry
Awards & highlights
Study Summary
This trial will test if a device that sends electrical signals to the brain can safely be used with chemotherapy to treat pediatric patients with recurrent brain tumors.
Who is the study for?
This trial is for pediatric patients with recurrent high-grade glioma or ependymoma brain tumors. Participants must have had prior tumor resection and radiation, be able to undergo MRI scans, and have adequate organ function. They should not have serious side effects from previous treatments, implanted electronic devices in the brain, significant bleeding disorders, or be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests the safety of using the Optune NovoTTF-200A device alongside chemotherapy in children with specific types of brain tumors. The device delivers electric fields intended to disrupt cancer cell growth while patients also receive standard drug treatment.See study design
What are the potential side effects?
Potential side effects may include skin irritation beneath device pads, headaches, malaise due to wearing the device for long periods, and typical chemotherapy-related issues like nausea, fatigue, lowered blood counts increasing infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years after study entry
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after study entry
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of the Optune NovoTTF-200A System when used alone in pediatric patients with recurrent high-grade gliomas.
Tolerability of the Optune NovoTTF-200A System when used alone in pediatric patients with recurrent high-grade gliomas.
Secondary outcome measures
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.
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Recurrent high grade gliomas and ependymomasExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
NovoCure Ltd.Industry Sponsor
57 Previous Clinical Trials
4,716 Total Patients Enrolled
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,238 Total Patients Enrolled
Derek Hanson, MDPrincipal InvestigatorJoseph M. Sanzari Children's Hospital at Hackensack University Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no allergies to Chinese hamster ovary cell products or human antibodies.I have a brain tumor that can be treated with TTFields despite having cancer spread to my lower brain or spinal cord.I don't have severe side effects from past cancer treatments.I agree to use effective birth control during and for 6 months after therapy.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.I am allergic to temozolomide or bevacizumab.I haven't had cancer treatment in the last 2-6 weeks, depending on the type.I must start treatment within 4 weeks after my high-grade brain tumor showed growth on an MRI.I do not have a brain tumor above the cerebellum.I am either younger than 5 or 18 years old or older.I haven't had surgery (except for shunt or line insertion) in the last 14 days.I've had the largest possible surgery to remove my tumor and radiation therapy as initial treatment.I have never had a blood clot and do not have a condition that makes clots more likely.I have had a significant brain bleed in the last month.I do not have symptoms of high pressure in my brain.I can have an MRI scan to check my cancer's progress.I have not had a stroke or any blockage in my arteries.I can take oral medications without severe vomiting.I do not have any known serious bleeding disorders.My high-grade glioma is new or has worsened after treatment. Or, my ependymoma has worsened after treatment.My blood, kidney, and liver tests meet the required levels.My liver and kidney functions are within normal ranges.I can take pills by mouth or have a tube for medication.I will start treatment within 6 weeks after my radiotherapy or surgery.I have no history of serious heart conditions or poorly controlled heart rhythm problems.I haven't taken any experimental drugs recently.I have been diagnosed with a specific type of brain tumor.My diagnosis is a high-grade brain tumor.My urine protein levels are low enough for me to join the trial.My head circumference is at least 44 cm.I can care for myself but may not be able to do active work or play.I do not have any serious wounds, ulcers, or unhealed bone fractures.
Research Study Groups:
This trial has the following groups:- Group 1: Recurrent high grade gliomas and ependymomas
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the current research effort including individuals of forty years or older?
"This research is specifically seeking participants aged 5-21."
Answered by AI
What is the current size of the cohort being evaluated by this trial?
"Affirmative. Data hosted on clinicaltrials.gov testifies to the active recruitment of trial participants for this medical experiment, which was initially posted in April 2017 and most recently modified in August 2022. 6 people are being enrolled from two distinct sites."
Answered by AI
Is Optune NovoTTF-200A System a viable option for long-term health and wellbeing?
"There is limited safety and efficacy data supporting the use of Optune NovoTTF-200A System, so it was assigned a score of 1."
Answered by AI
Are any additional participants being accepted for this research project?
"From the information available on clinicaltrials.gov, it is clear that this research project is in search of patients at present. This trial was initially announced on April 6th 2017 and its primary details were edited most recently on August 12th 2022."
Answered by AI
Are there specific demographics that are ideal candidates for this research?
"This medical study requires 6 applicants with ependymoma aged between 5 and 21. To be accepted, they must meet a range of criteria: enrolment prior to treatment; beginning therapy within two weeks post-enrolment; having received the maximum feasible resection followed by radiation (unless contraindicated due to age); possessing a minimum head circumference of 44cm; being newly diagnosed or showing signs of progression/recurrence following standard treatments for high-grade gliomas or ependymomas."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger