Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas

• Status: Terminated
• Trial end date: 2020-07-27
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the effectiveness and safety of the NovoTTF-200A device in patients with low-grade glioma when it's used by itself or used together with temozolomide. Researchers would also like to know whether the use of NovoTTF-200A, with or without temozolomide, is associated with fewer negative side effects on mental function that may be seen with other currently used treatment options.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santosh Kesari
• Collaborator: NovoCure Ltd.
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pilocytic astrocytoma, ganglioglioma, pleomorphic xanthoastrocytoma, 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.