Trial Summary
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
What safety data is available for Tumor Treating Fields (TTFields) treatment?The safety data for Tumor Treating Fields (TTFields), also known as the Optune device, indicates that the most common adverse event is dermatologic, primarily skin toxicities. These skin issues are more frequent compared to other adverse events like headaches. Preventative strategies can help manage these dermatological events. The safety of TTFields in combination with other therapies, such as bevacizumab, is still being studied. TTFields have been FDA approved for recurrent glioblastoma since 2011 and for newly diagnosed glioblastoma since 2015, demonstrating improved survival rates when used with temozolomide.23456
Is the Optune device a promising treatment for brain cancer?Yes, the Optune device is a promising treatment for brain cancer. It uses Tumor Treating Fields (TTFields), which are electric fields that help stop cancer cells from growing. Studies have shown that when used with the drug temozolomide, Optune improves survival rates for patients with glioblastoma, a type of brain cancer. It is non-invasive, meaning it doesn't require surgery, and has been approved by the U.S. Food and Drug Administration for treating both newly diagnosed and recurrent glioblastoma. The device is also lighter and more comfortable to use in its second-generation version.12356
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational agents or devices within 21 days before starting the study device.
What data supports the idea that Tumor Treating Fields for Brain Cancer is an effective treatment?The available research shows that Tumor Treating Fields (TTFields) are effective for treating glioblastoma, a type of brain cancer. In a phase 3 clinical trial, TTFields were as effective as chemotherapy for patients with recurrent glioblastoma and had fewer side effects. For newly diagnosed glioblastoma, adding TTFields to standard treatments like radiation and chemotherapy improved survival rates. This suggests that TTFields can be a valuable addition to existing treatments for brain cancer.12356
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
I am able to care for myself but may not be able to do active work.
I am 18 years old or older.
My blood and organ functions are within the required ranges for treatment.
Exclusion Criteria
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
I haven't had major heart or blood vessel problems in the last 3 months.
Treatment Details
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.
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.
Optune device is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as Optune for:
- Newly diagnosed glioblastoma
- Recurrent glioblastoma
🇪🇺 Approved in European Union as Optune for:
- Newly diagnosed glioblastoma
- Recurrent glioblastoma
🇯🇵 Approved in Japan as Optune for:
- Newly diagnosed glioblastoma
- Recurrent glioblastoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
Emory University/Winship Cancer InstituteAtlanta, GA
Emory Proton Therapy CenterAtlanta, GA
Emory Saint Joseph's HospitalAtlanta, GA
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Who is running the clinical trial?
Emory UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Technological Advances in the Treatment of Cancer: Combining Modalities to Optimize Outcomes. [2016]The anticancer treatment modality tumor treating fields (TTFields; Optune, Novocure) use the lower frequency range of the electromagnetic spectrum to destroy tumor cells during mitosis. This treatment has been evaluated in several trials of patients with glioblastoma. In these patients, TTFields are delivered through 4 transducer arrays applied to the scalp. In a phase 3 clinical trial of patients with recurrent glioblastoma, TTFields were as effective as chemotherapy, and were associated with fewer and milder systemic toxicities. Data from a phase 3 trial in newly diagnosed glioblastoma suggested that the addition of TTFields to postoperative radiation therapy and chemotherapy represents an important advance in the management of newly diagnosed glioblastoma. Ongoing clinical trials are investigating the efficacy and safety of TTFields in other tumor types, including pancreatic cancer, mesothelioma, ovarian cancer, and non–small cell lung cancer. Other recent advances in the management of cancer have been seen with immunomodulatory therapy, including immune checkpoint inhibitors. Further study will be necessary to evaluate whether TTFields will enhance or impair other established and newly emerging therapies.
Optune®: Practical Nursing Applications. [2018]After receiving U.S. Food and Drug Administration approval for the treatment of newly diagnosed glioblastoma (GBM) in 2015, following initial approval for treatment of recurrent GBM in 2011, Optune®, a device that uses tumor-treating fields (TTFields) therapy, continues to gain acceptance in the practice environment.
Tumor-Treating Fields: Nursing Implications for an Emerging Technology . [2018]Tumor-treating fields (TTFields) are a new technology used for cancer treatment consisting of battery-powered, insulated electromagnetic transducers that are placed on the scalp. This wearable, adhesive device is a certified physician-prescribed therapy for patients with glioblastoma multiforme, a type of primary brain cancer. TTFields are being used concomitantly with temozolomide (Temodar®) in patients with newly diagnosed glioblastoma and as a monotherapy in patients with recurrent glioblastoma after radiation therapy and chemotherapy. Nursing professionals caring for patients using this emerging technology should be able to educate patients regarding proper use of TTFields and monitor for side effects. .
Skin toxicities associated with tumor treating fields: case based review. [2018]The novel anti-mitotic based tumor treating fields (TTFields) is FDA approved for recurrent glioblastoma. Recently the phase III upfront trial combining the Novo TTF-100A device, called Optune, with temozolomide following concurrent radiation therapy and chemotherapy, demonstrated improvement in survival. Wider use of this novel therapy is expected. The most common adverse event is dermatologic, which dominates compared to the next most frequently observed adverse event of headaches, the incidence of which was even in both arms in the phase III registration trial for recurrent glioblastoma. Our case review outlines the presentation, treatment, and outcome of representative patients using TTFields. In summary, preventative strategies to inform and educate patients and operators can prevent many of these dermatological events. Skin toxicity in the setting of concurrent use of TTFields with other therapies such as bevacizumab is an unknown and will need to be closely followed.
Tumor Treating Fields Technology: Alternating Electric Field Therapy for the Treatment of Solid Tumors. [2018]To provide an overview of Tumor Treating Fields (TTFields) and the Optune device in the treatment of glioblastoma multiforme as well as discuss the evolution of TTFields technology for the treatment of different tumor types.
Tumor Treating Fields for Glioblastoma Treatment: Patient Satisfaction and Compliance With the Second-Generation Optune® System. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Tumor treating fields (TTFields) are a non-invasive antimitotic therapy that delivers alternating electric fields via the Optune® system. The Phase III EF-14 trial in newly diagnosed glioblastoma multiforme (GBM) showed significantly improved progression-free, overall and long-term survival when Optune was used together with maintenance temozolomide (TMZ) compared with TMZ alone. Compliance (average monthly use) was associated with better clinical outcome. The first-generation Optune system weighed approximately 6 pounds (~2.7 kg). The second-generation redesigned Optune system weighs 2.7 pounds (~1.2 kg). We tested and compared GBM patient experience with the second-generation system versus the first-generation system.