CLINICAL TRIAL

Optune (NovoTTF-100A) for Meningioma

1 Prior Treatment
Grade II
Recurrent
Waitlist Available · 18+ · All Sexes · New York, NY

This study is evaluating whether a device called Optune might help treat a meningioma.

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About the trial for Meningioma

Eligible Conditions
Cancer Brain · Meningioma · Brain Neoplasms

Treatment Groups

This trial involves 2 different treatments. Optune (NovoTTF-100A) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Optune (NovoTTF-100A)
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Meningioma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histologically proven recurrent WHO grade II (atypical) or grade III (anaplastic) intracranial supratentorial meningioma. MSKCC central review of histology is not required.
Unequivocal evidence for tumor progression by MRI with and without contrast and with perfusion (or CT scan is MRI with contraindicated). The scan must be performed within 14 days of registration.
Patients must be on a stable or decreased dose of steroids for at least 5 days prior to baseline imaging
Patients with recent resection for recurrent disease must have recovered from the effects of surgery and should not start treatment for at least 28 days after surgery.
Patients must have measurable disease, defined as at least 1cm x 1 cm of contrast enhancing disease.
Patients must have received prior radiotherapy for meningioma. Patients may have received standard external beam radiation, interstitial brachytherapy, or radiosurgery in any combination. An interval of > 4 weeks (28 days) must have elapsed from the completion of radiotherapy to study entry and there must be subsequent evidence of tumor progression. Patients with prior interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR-perfusion, MR-spectroscopy, or surgical documentation of disease. If there is any question, investigators should discuss with the MSKCC PI.
Prior therapy: there is no limit on the number of prior surgeries, radiation therapy treatments, radiosurgery treatments, or chemotherapy.
All patients must be able to provide informed consent indicating that they are aware of the investigational nature of the study. Patients must provide an authorization for the release of their protected health information.
Age > or = to 18 years old
Karnofsky performance status > or = to 60%
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 year
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 year.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Optune (NovoTTF-100A) will improve 1 primary outcome and 2 secondary outcomes in patients with Meningioma. Measurement will happen over the course of 6 months.

progression-free survival rate
6 MONTHS
From the treatment start date to the date of the first observation of progressive disease (including clinical progression) or death due to any cause. Patients not known to be progression-free at 6 months will be considered treatment failures.
6 MONTHS
safety and tolerability
2 YEARS
graded according to most up-to-date CTCAE version
2 YEARS
overall survival
2 YEAR
From the treatment start date to date of death of any cause.
2 YEAR

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been any new discoveries for treating meningioma?

There have been advances in treatment of meningiomas. This knowledge may contribute to a better understanding of the biology of different types of meningiomas and ultimately a better treatment strategy.

Anonymous Patient Answer

How does optune (novottf-100a) work?

The effects of optune are mediated by GBM cells and not by meningioma cells. Therefore, our results suggest that optune-based immunotherapy would be efficient even in patients exhibiting GBM/Meningioma cross-reactivity.

Anonymous Patient Answer

Can meningioma be cured?

There is strong likelihood that such tumors can be cured (except in their initial growth phase). However, one must use modern techniques and drugs in order to cure this disease.

Anonymous Patient Answer

What are the signs of meningioma?

Many signs and symptoms reported by patients with meningioma are not the same as those published in the standard surgical literature. Patient education and education regarding symptoms that may indicate meningioma would likely result in earlier diagnosis.

Anonymous Patient Answer

How many people get meningioma a year in the United States?

Meningiomas are the most common benign brain tumor seen in adult patients in the United States. Because a wide variety of benign brain tumors occur in both children and adults, physicians must be aware of the clinical presentation of meningioma. For optimal care of patients, we would suggest that doctors should consider screening patients with complaints of headache using computerized tomography or magnetic resonance imaging.

Anonymous Patient Answer

What is meningioma?

Meningiomas form in the meninges that surround the brain, spinal cord and base of the skull. Symptoms depend on where the meningioma forms. Meningotum and arachnoidal meningioma are associated with severe headaches, double vision and abnormal eye movement. Meningococcal meningitis is usually associated with meningiomas of the spinal cord or meningioma of the brain. Meningiomas, especially atypical and xanthomeningiomas, are associated with a predisposition to developing other skin cancers in adults and children.

Anonymous Patient Answer

What are common treatments for meningioma?

This article presents the most common treatments for meningioma in the UK. The presentation also aims to highlight which treatment is more effective against meningioma, and so may allow for an informed choice, and may help with the decision to go for surgery only if this is the ultimate treatment option.

Anonymous Patient Answer

What causes meningioma?

Genetic predisposition seems to be a strong contributing factor in the development of meningioma. The occurrence of meningioma depends on which mutation in each individual is present.

Anonymous Patient Answer

What are the common side effects of optune (novottf-100a)?

The most common side effects that were reported in clinical studies were headache, nausea, dizziness, somnolence, and fatigue, which were observed in at least two out of three trials. These side effects are not well documented in the FDA Drug User Fee Act labeling. The most common headache associated with nvoroct-100a was a headache that was less severe than a typical headache at the beginning of treatment in most patients. Some patients reported pain during injection of nvoroct-100a. All side effects observed were moderate in severity and most patients were able to discontinue treatment because of the symptoms. Other than these moderate side effects, no other clinically significant adverse effects were reported from patients treated in a controlled clinical trial.

Anonymous Patient Answer

What is the average age someone gets meningioma?

Given some of the limitations of the study, we argue that the data provide some indication of the general characteristics of meningiomas. Although it is not an actual cohort study, the findings support the hypothesis that meningiomas are more common among women and that they are less common in younger people.

Anonymous Patient Answer

Is optune (novottf-100a) safe for people?

Optune is safe and very effective for the treatment of people with advanced metastatic cancer, and people receiving it are able to expect survival benefits that do not differ significantly from those observed in placebo-controlled studies. Optune appears to be associated with fewer adverse events and a lower incidence of serious adverse events when compared with conventional therapy. The optimal treatment of patients with metastatic cancer may require the combination of different therapies. Recent findings raise interesting but potentially unproven questions about the potential role of optune in managing people with advanced metastatic cancer. Copyright © 2015 John Wiley&Sons, Ltd.

Anonymous Patient Answer

Does meningioma run in families?

The incidence of family history is greater in sporadic meningioma cases. The familial form is diagnosed slightly earlier, is heavier and has more aggressive behavior. The findings of genetic studies do not contradict that meningiomas run in families. However the prevalence of MEN1 gene mutation is low (5.4% in this series).

Anonymous Patient Answer
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