Tumor Treating Fields for Brainstem Gliomas
This study is testing a treatment called Tumor Treating Fields (TTFields) for people with gliomas (a type of brain tumor) in the brainstem. TTFields use low-intensity electric fields to interfere with cancer cell division. You would wear a device called Optune, which delivers these fields. The main goal is to see if Optune is safe and well-tolerated when used with standard radiation and chemotherapy. Researchers will also look at how well the treatment works to slow tumor growth and improve survival. This study is for adults aged 18 or older with a good general health status and a life expectancy of more than 12 weeks. The study plans to enroll 10 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants receive a specific treatment. It plans to enroll 10 participants.
- What's involved
- You would wear the Optune device for at least 18 hours per day for 12 months, as long as the disease doesn't worsen or side effects aren't too severe. You would have follow-up visits at 3, 6, 9, and 12 months during treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 12 months of study treatment, you would have follow-up visits every 3-6 months.
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NCT05310448
Tumor Treating Fields for the Treatment of Brainstem Gliomas
Recruiting
NAAges 18+InterventionalTreatmentEmory UniversityInvestigator-initiated
~10 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:Optune device
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 12 months after TTFields started
Conditions
Where it's being run
3 sites across 1 statesGeorgia3
Study leadership
- Jim Zhong, MD · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 findings.
Completion of all previous therapy (including surgery and radiotherapy) for the treatment of cancer \>= 4 weeks before the start of study therapy.
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocolspecified laboratory tests, other study procedures, and study restrictions.
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
Patients must have adequate organ and marrow function, within 28 days of Cycle 1 Day 1 of Temozolomide, as defined below:
Hemoglobin \>= 9.0 g/dl (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1 of temozolomide)
White blood cell (WBC) \>= 2000/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1 of temozolomide)
Absolute neutrophil count (ANC) \>= 1,500/mcL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1 of temozolomide)
Platelets \>= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1 of temozolomide)
Prothrombin time (PT)/partial thromboplastin time (PTT) =\< 1.5 x upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
Total bilirubin =\< 2 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 institutional upper limit of normal (ULN) (within 28 days of cycle 1 day 1 of temozolomide)
Serum creatinine =\< 2 mg/dL (or glomerular filtration rate \>= 40 mL/min) (within 28 days of cycle 1 day 1 of temozolomide)
The effects of combination therapy with tumor treating fields (TTF) and temozolomide on the developing human fetus are unknown. For this reason and because other therapies used in this trial are known to be teratogenic, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy.
FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of TTF and Temozolomide administration. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months.
Exclusion
Patients who are receiving any other investigational agents or an investigational device within 21 days before first administration of study device.
History of allergic reactions attributed to compounds of similar composition to those used for transducer placement.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Significant cardiovascular disease (eg, myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; or uncontrolled Grade ≥3 hypertension (diastolic blood pressure ≥100 mmHg or systolic blood pressure ≥160 mmHg) despite antihypertensive therapy.
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of increased risk of lethal infections when treated with marrow-suppressive therapy such as Temozolomide. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
What this trial measures
- Incidence of adverse eventsUp to 12 months after TTFields started
Adverse event rates will be summarized descriptively using frequencies and percentages in addition to a tolerability rate defined as composite of any dose-limiting toxicity.