Actively Recruiting
Tumor Treating Fields for the Treatment of Brainstem Gliomas
Led by Emory University · Updated on 2025-09-26
10
Participants Needed
3
Research Sites
259 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Tumor Treating Fields for the Treatment of Brainstem Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Karnofsky performance status of 70% or higher
- Life expectancy greater than 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; diagnosis confirmed by biopsy or maximal safe resection preferred
- Completion of all prior cancer therapies including surgery and radiotherapy at least 4 weeks before starting study treatment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and study procedures
- Signed informed consent acknowledging understanding of the disease and study details
- Adequate organ and marrow function within 28 days before starting temozolomide, including specified blood counts, coagulation times, and liver and kidney function
- Negative pregnancy test for females of child-bearing potential prior to therapy start
- Agreement to use adequate contraception for females of child-bearing potential and men before and during study participation, and for men up to 12 months after treatment completion
You will not qualify if you...
- Completion of chemotherapy or radiotherapy more than 26 weeks before study entry
- Receiving other investigational drugs or devices within 21 days before starting the study device
- History of allergic reactions to compounds similar to those used for transducer placement
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric/social conditions limiting compliance
- Significant cardiovascular disease within 3 months before study start, including recent heart attack, thromboembolism, symptomatic peripheral vascular disease, severe heart failure, or uncontrolled high blood pressure
- HIV-positive patients on combination antiretroviral therapy due to risk with marrow-suppressive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Emory Proton Therapy Center
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
2
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Not Yet Recruiting
Research Team
J
Jim Zhong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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