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|NCT02507232 : A Phase II Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas|
|Ages||Min: 18 Years Max: N/A|
- Histologically confirmed low-grade glioma including astrocytoma grade 2,
oligodendroglioma grade 2, or oligoastrocytoma grade 2.
- Tumor is supratentorially located and measureable.
- Disease that has not received prior radiation, radiosurgery, chemotherapy, or other
investigational treatment directed at the brain tumor at any time. Previous surgical
procedures is allowed.
- Age = 18 years.
- Life expectancy > 12 weeks.
- Either not receiving steroids for disease symptoms or are on stable dose of steroids
for at least 5 days.
- Karnofsky Performance Status (KPS) = 60%
- Adequate hematologic function evidenced by:
- Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- Platelet count = 100 x 109/L
- Hemoglobin = 9.0 g/dL
- Adequate renal function evidenced by:
- AST/SGOT and ALT/SPGT = 2.5 X institutional upper limit of normal
- Total bilirubin = 1.5 x institution's ULN
- Serum creatinine = 1.5 x institution's ULN
- Pilocytic astrocytoma, ganglioglioma, pleomorphic xanthastrocytoma, or
dysembryoplastic neuroepithelial tumors are not eligible.
- Current or anticipated use of other investigational agents.
- Implanted electronic medical device in the brain (e.g., deep brain stimulator, vagus
nerve stimulator, programmable shunt).
- Patients who are less than 4 weeks from surgery or have insufficient recovery from
surgical-related trauma or wound healing.
- Severe or uncontrolled medical disorder that would, in the investigator's opinion,
impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal
disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric
illness/social situations that would limit compliance with study requirements).
- Severe cardiac insufficiency (NYHA III or IV), with uncontrolled and/or unstable
cardiac or coronary artery disease.
- Pregnant or nursing.
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| Link to official Clinicaltrials.gov listing