Tumor Treating Fields: Pilot Study of Adjuvant Treatment for Brainstem Gliomas
Emory University
Summary
This clinical trial tests the safety and side effects of tumor treating fields in treating patients with gliomas located in the brainstem. Optune is a wearable, portable, treatment that creates low-intensity, wave-like electric fields called tumor treating fields (TTFields), which interfere with cancer cell division. TTFields may prevent growth or decrease size of gliomas in patients
Description
PRIMARY OBJECTIVE: I. To evaluate the safety and tolerability of tumor treating fields in combination with standard of care radiotherapy and chemotherapy in patients with brainstem gliomas. SECONDARY OBJECTIVE: I. To evaluate the anti-tumor activity of the combination of radiotherapy, chemotherapy, and tumor treating fields by assessing progression-free survival (PFS), overall response rate, and overall survival (OS). TERTIARY/EXPLORATORY OBJECTIVE: I. To assess the effects of the tumor treating fields on neurocognitive function. OUTLINE: Beginning after start of standard of care radiat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years * Karnofsky performance status \>= 70% * Life expectancy \> 12 weeks as determined by the investigator * Diagnosis of glioma with at least partial involvement or invasion of thalamus, cerebral peduncles, midbrain, pons, or medulla. Confirmation of diagnosis by biopsy or maximal safe resection preferred. If multi-disciplinary tumor board recommend no benefit and likely harm of attempting biopsy then can establish consensus clinical diagnosis. If foregoing biopsy then tumor board will estimate tumor stage based on clinical presentation and radiographic fin…
Interventions
- DeviceOptune device
Wear Optune device
Locations (3)
- Emory Proton Therapy CenterAtlanta, Georgia
- Emory University/Winship Cancer InstituteAtlanta, Georgia
- Emory Saint Joseph's HospitalAtlanta, Georgia