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Device

Tumor Treating Fields for Brain Cancer

N/A

Recruiting

Led By Jim Zhong, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status >= 70%

Age >= 18 years

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ttfields start to death from any cause, assessed up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new brain cancer treatment that uses low-intensity electric fields to interfere with cancer cell division.

Who is the study for?

Adults with brainstem gliomas who've finished cancer therapy at least 4 weeks prior, have a life expectancy over 12 weeks, and can follow the study plan. They need normal organ/marrow function and must use birth control. Excluded are those with uncontrolled illnesses, recent significant cardiovascular events, HIV on antiretroviral therapy, or recent investigational treatments.

What is being tested?

The trial is testing the Optune device's safety and side effects for patients with brainstem gliomas. The device delivers low-intensity electric fields to disrupt cancer cell division in hopes of stopping tumor growth or shrinking it.

What are the potential side effects?

Specific side effects of the Optune device aren't detailed here but may include skin irritation under the device pads, headaches, malaise or other discomfort related to wearing the device continuously.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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I am 18 years old or older.

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My blood and organ functions are within the required ranges for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I haven't had major heart or blood vessel problems in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ttfields start to death from any cause, assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from ttfields start to death from any cause, assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from ttfields start to death from any cause, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Overall response rate

Overall survival (OS)

Progression free survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (tumor treating fields)Experimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met