Clinical Trial Details
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NCT01892397 : Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Histologically proven recurrent WHO grade II (atypical) or grade III (anaplastic)
intracranial supratentorial meningioma. MSKCC central review of histology is not

- 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

- 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%

- 4 weeks (28 days) from any radiation treatment, stereotactic radiosurgery,
conventional surgery, or chemotherapy.

- Life expectancy at least 3 months

- Patients with NF (Neurofibromatosis) are eligible, and may have other stable CNS
tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these
lesions have been stable in size for the preceding 6 months.

Exclusion Criteria:

- Patients with a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ of the cervix, unless in complete remission and off all therapy for
the disease for a minimum of 3 years).

- Concomitant use of any other investigational drugs.

- Concurrent treatment on another clinical trial. Supportive care trials or
non-treatment trials (i.e. Quality of life) are allowed.

- Pregnancy or breast feeding. Patients must be surgically sterile, postmenopausal, or
agree to use effective contraception during the period of therapy. The definition of
effective contraception will be based on the judgment of the principal investigator
or a designated associate. Male patients must be surgically sterile or agree to
effective contraception. Female patients of child bearing potential (ages 11-55) must
have a negative B-HCG pregnancy test documented within 14 days prior to registration.

- Implanted medical device such as a pacemaker, defibrillator, deep brain stimulator,
or vagus nerve stimulator, or documented significant arrhythmia at the discretion of
the investigator.

- Evidence of increased intracranial pressure (midline shift >5mm, clinically
significant papilledema, vomiting and nausea, or reduced level of consciousness).

- Infratentorial meningioma (patients may have infratentorial meningioma if there is
concurrent growing supratentorial meningioma that serves as the target lesion)

- Coagulopathy (as evidenced by PT or APTT >1.5 times upper limit of normal in patients
not undergoing anticoagulation)

- Thrombocytopenia (platelet count <100x10^3/uL) Neutropenia (absolute neutrophil count

- Severe acute infection

- Skull defect with missing bone

- Ventricular shunt/catheter

- Presence of a foreign body intracranially such as a bullet fragment
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