BIP_JWCI-16-1101

A Multicenter, Open-Label, Randomized Study of NovoTTF-200A Alone and Combined with Temozolomide in Patients with Low-Grade Gliomas

Key Inclusion Criteria:
-Histologically confirmed, measureable low-grade glioma including grade 2 astrocytoma, oligdendroglioma, or oligastrocytoma.
-Previous surgery, radiation, or chemotherapy are ok
-Age > 18
-KPS score > 60%
-Must be able to provide consent

Key Exclusion Criteria:
-Implanted electronic medical device (e.g. deep brain stimulator, vagus nerve stimulator, programmable shunt)
-Subject less than 4 weeks post-surgery or who have insufficient recovery from surgery
-Severe cardiac insufficiency or other severe/uncontrolled medical condition that would impair subject’s ability to receive study treatment
-Current or anticipated use of other investigational agents
-Pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, or dysembryoplastic neuroepithelial tumors

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**

Phase II
NCT02507232
Neurosciences
Neuro-oncology
Ricky Chen, M.D.
John Wayne Cancer Institute
Lynette Currie
  • Providence St. Vincent Medical Center