Using electric fields to treat brainstem gliomas

Tumor Treating Fields: Pilot Study of Adjuvant Treatment for Brainstem Gliomas

This study is testing whether wearing a device that uses electric fields along with standard treatments can help people with brainstem gliomas feel better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Atlanta, Georgia and 2 other locations)
• Trial ID: NCT05310448 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and side effects of tumor treating fields (TTFields) in patients with gliomas located in the brainstem. The Optune device, which generates low-intensity electric fields, is worn for at least 18 hours a day in conjunction with standard radiotherapy and chemotherapy. The study aims to assess the tolerability of this combination treatment, its anti-tumor activity, and its effects on neurocognitive function over a 12-month period. Patients will be monitored for progression-free survival, overall response rate, and overall survival.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of glioma involving the brainstem and a Karnofsky performance status of 70% or higher.

Not a fit: Patients with gliomas that do not involve the brainstem or those who have not completed prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with brainstem gliomas by enhancing tumor control and potentially preserving cognitive function.

How similar studies have performed: While the use of tumor treating fields is a novel approach for brainstem gliomas, similar studies in other types of cancers have shown promising results.

Eligibility criteria

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 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:

Hematology:

* 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)

Chemistry

* 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 Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

\- Patients who have completed chemotherapy or radiotherapy more than 26 weeks prior to entering the study.

i. Completion of radiotherapy 8-12 weeks prior to starting the tumor treating fields will be considered a minor deviation.

ii. Completion of radiotherapy 13-26 weeks prior to starting the tumor treating fields will be considered a major deviation.

* 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.

Where this trial is running

Atlanta, Georgia and 2 other locations

• Emory Proton Therapy Center — Atlanta, Georgia, United States (Not_yet_recruiting)
• Emory University/Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Jim Zhong, MD — Emory University Hospital/Winship Cancer Institute
• Study coordinator: Jim Zhong, MD

Conditions Glioma