Tumor Treating Fields for the Treatment of Brainstem Gliomas

NCT05310448 | Recruiting DMC FDA Device

• 4 other identifiers: STUDY00003027NCI-2021-09679WINSHIP5412-21P30CA138292
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  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.

  Up to 12 months after TTFields started

Secondary Outcomes (3)

• Progression free survival (PFS)

  From TTFields start to disease progression or death, assessed up to 36 months

• Overall response rate

  Up to 12 months after TTFields started

• Overall survival (OS)

  From TTFields start to death from any cause, assessed up to 36 months

Study Arms (1)

Treatment (tumor treating fields)

EXPERIMENTAL

After completion of standard of care radiation therapy, patients wear the Optune device for 18 hours per day for 12 months in the absence of disease progression or unacceptable toxicity.

Device: Optune device

Interventions

Optune device DEVICE

Wear Optune device

Also known as: Alternating Electric Field Therapy, TTF, TTFields, Tumor Treating Fields Therapy

Treatment (tumor treating fields)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Emory Proton Therapy Center

Atlanta, Georgia, 30308, United States

NOT YET RECRUITING

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Jim Zhong, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jim Zhong, MD

CONTACT

404-778-3473; jzhong@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: April 5, 2022
• Study Start: May 11, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (3)