Tumor Treating Fields for Brain Cancer
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on investigational agents or devices, you must stop them at least 21 days before starting the study.
What data supports the effectiveness of the treatment Optune device for brain cancer?
Research shows that the Optune device, which uses Tumor Treating Fields (TTFields), improves survival rates in patients with newly diagnosed glioblastoma when used with the chemotherapy drug temozolomide. It has been found to be as effective as chemotherapy for recurrent glioblastoma, with fewer side effects.12345
Is the Optune device safe for use in humans?
The Optune device, which uses Tumor Treating Fields (TTFields) therapy, is generally considered safe for humans, with the most common side effect being skin irritation where the device is applied. Other less common side effects include headaches, and preventative strategies can help manage skin issues.12456
How is the Optune device treatment different from other brain cancer treatments?
The Optune device uses Tumor Treating Fields (TTFields), which are alternating electric fields that disrupt cancer cell division, making it unique compared to traditional treatments like chemotherapy and radiation. It is a non-invasive, wearable device applied to the scalp, offering a different approach with fewer systemic side effects.12345
What is the purpose of this trial?
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
Research Team
Jim Zhong
Principal Investigator
Emory University Hospital/Winship Cancer Institute
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Standard of care radiation therapy is administered
Treatment
Participants wear the Optune device for at least 18 hours per day for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Optune device
Optune device is already approved in United States, European Union, Japan for the following indications:
- Newly diagnosed glioblastoma
- Recurrent glioblastoma
- Newly diagnosed glioblastoma
- Recurrent glioblastoma
- Newly diagnosed glioblastoma
- Recurrent glioblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator