Tumor Treating Fields for Brain Cancer

Recruiting at 2 trial locations

Overseen By Jim Zhong, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Temozolomide

Must not be taking: Antiretrovirals

Disqualifiers: Cardiovascular disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of a treatment called tumor treating fields (TTFields) for individuals with brainstem gliomas, a type of brain cancer. The treatment uses a wearable device called Optune, which sends low-intensity electric fields to the brain to inhibit cancer cell growth. Individuals who have had a glioma affecting brain areas such as the thalamus or medulla and have completed other cancer treatments like surgery and radiation may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could potentially benefit future patients.

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 prior data suggests that the Optune device is safe for treating brainstem gliomas?

Research has shown that Tumor Treating Fields (TTFields) therapy, using the Optune device, is generally safe for patients. Studies have found that TTFields have a good safety record. This treatment targets the tumor area directly, sparing the rest of the body. Real-world data also confirm its safety, even in children with brain tumors, with no new safety issues identified.

In summary, TTFields therapy with the Optune device is well-tolerated, with no major safety concerns reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for brain cancer, which typically involve surgery, radiation, and chemotherapy, the Optune device offers a novel approach by using tumor treating fields (TTFields). This method involves wearing the device on the scalp to emit low-intensity, alternating electric fields that disrupt cancer cell division. Researchers are excited about Optune because it provides a non-invasive, targeted method to slow down tumor growth without the systemic side effects associated with traditional chemotherapy. This unique mechanism of action holds promise for improving quality of life and potentially extending survival for patients with brain cancer.

What evidence suggests that the Optune device is effective for brain cancer?

Research has shown that Optune, a device using electric fields to treat tumors, holds promise for treating glioblastoma, a type of brain cancer. In this trial, participants will use the Optune device after completing standard radiation therapy. Studies have found that patients using Optune lived longer, with some surviving up to 20.9 months compared to 16 months with standard treatment. Progression-free survival, the period during which the cancer did not worsen, also improved for those using Optune. Specifically, another study showed that patients lived about 19.6 months on average, with the cancer not progressing for around 10.2 months. These findings suggest that Optune might help slow down or shrink brain tumors. ^{1 2 5 6 7}

Who Is on the Research Team?

Jim Zhong

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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

Life expectancy > 12 weeks as determined by the investigator

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

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

Exclusion Criteria

History of allergic reactions attributed to compounds of similar composition to those used for transducer placement

I finished my chemotherapy or radiotherapy more than 6 months ago.

Patients who are receiving any other investigational agents or an investigational device within 21 days before first administration of study device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Standard of care radiation therapy is administered

6-8 weeks

Treatment

Participants wear the Optune device for at least 18 hours per day for 12 months

12 months

Follow-up visits at 3, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Follow-up every 3-6 months

What Are the Treatments Tested in This Trial?

Interventions

• Optune device

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (tumor treating fields) Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Optune® uses tumor-treating fields (TTFields) therapy, which is a novel approach to treating newly diagnosed glioblastoma (GBM) that differs from traditional methods, emphasizing the importance of continuous daily use for optimal patient outcomes.

Oncology nurses play a crucial role in educating patients about TTFields therapy, ensuring adherence to treatment, and helping patients integrate the use of Optune into their daily lives, which can enhance the effectiveness of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optune®: Practical Nursing Applications. Murphy, J., Bowers, ME., Barron, L.[2018]

The second-generation Optune system, which is lighter and more portable than the first-generation model, has led to improved patient satisfaction and compliance in newly diagnosed and recurrent glioblastoma multiforme (GBM) patients.

In a study of 10 GBM patients, most reported fewer malfunction alarms and better handling of the second-generation system, which may contribute to better treatment adherence and potentially improved clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Treating Fields for Glioblastoma Treatment: Patient Satisfaction and Compliance With the Second-Generation Optune® System. Kinzel, A., Ambrogi, M., Varshaver, M., et al.[2022]

Tumor-treating fields (TTFields) are a novel, physician-prescribed therapy for glioblastoma multiforme, used alongside temozolomide for newly diagnosed patients and as a standalone treatment for recurrent cases.

Nursing professionals play a crucial role in educating patients on the proper use of TTFields and monitoring for potential side effects, ensuring safe and effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor-Treating Fields: Nursing Implications for an Emerging Technology . Chang, A.[2018]

Tumor treating fields (TTFields) have been shown to be as effective as chemotherapy in treating recurrent glioblastoma while causing fewer and milder side effects, making it a safer option for patients.

In newly diagnosed glioblastoma, adding TTFields to standard postoperative treatments (radiation and chemotherapy) represents a significant advancement, and ongoing trials are exploring its effectiveness in other cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological Advances in the Treatment of Cancer: Combining Modalities to Optimize Outcomes. Wong, ET., Toms, SA., Ahluwalia, MS.[2016]

Tumor Treating Fields (TTFields) and the Optune device are effective treatment options for glioblastoma multiforme, representing a novel approach in cancer therapy.

Oncology nurses play a crucial role in educating and supporting patients and caregivers in the use of TTFields, helping them understand the treatment's mechanism, manage side effects, and ensure adherence for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Treating Fields Technology: Alternating Electric Field Therapy for the Treatment of Solid Tumors. Benson, L.[2018]

The use of tumor treating fields (TTFields) with the Novo TTF-100A device, known as Optune, has been shown to improve survival in patients with recurrent glioblastoma when combined with temozolomide after radiation therapy, indicating its efficacy as a treatment option.

The most common side effect of TTFields is dermatologic issues, but with proper education and preventative strategies, many of these skin-related events can be minimized, highlighting the importance of patient management in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin toxicities associated with tumor treating fields: case based review. Lukas, RV., Ratermann, KL., Wong, ET., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10695547/

Efficacy of tumour-treating fields therapy in recurrent ... This review synthesizes the current evidence surrounding the efficacy of TTFields Therapy in the context of recurrent Glioblastoma.

2. novocure.com novocure.com/tiger-study-reports-new-ttfields-therapy-survival-results-for-newly-diagnosed-glioblastoma-patients-in-germany

TIGER Study Reports New TTFields Therapy Survival ... Median overall survival for patients treated with TTFields therapy was 19.6 months (95% CI, 17.9-22.4). Median progression-free survival was 10.2 months (95% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8278345/

Tumor-Treating Fields for the treatment of glioblastoma Tumor-Treating Fields (TTFields) is an emerging treatment modality for glioblastoma (GBM). Studies have shown a good safety profile alongside improved efficacy.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586825003686

Tumor treating fields utilization and efficacy for ... Tumor treating fields (TTF) improved progression-free survival (7.1 versus 4.0 months) and overall survival (20.9 months versus 16.0 months) in a phase III ...

5. academic.oup.com academic.oup.com/oncolo/article/30/2/oyae227/7821273

Recent advances in Tumor Treating Fields (TTFields) therapy ... For the latter, results from a 30-patient study showed a median PFS of 9.3 months, median OS of 15.8 months, and 1-year survival of 66% ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9443515/

Safety of Tumor Treating Fields (TTFields) therapy in pediatric ... The real-world data reported here demonstrate that TTFields therapy has a favorable safety profile for pediatric patients with brain tumors, with no new safety ...

7. novocuretrials.com novocuretrials.com/cancer-clinical-trials/glioblastoma-clinical-trial-trident

TRIDENT - Glioblastoma Clinical Trial | Novocure Trials This clinical trial is evaluating the safety and efficacy of Tumor Treating Fields (TTFields) delivered by the Optune treatment paired with radiation therapy ...