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

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 3 4 5}

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Optune®: Practical Nursing Applications. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Technological Advances in the Treatment of Cancer: Combining Modalities to Optimize Outcomes. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Tumor Treating Fields for Glioblastoma Treatment: Patient Satisfaction and Compliance With the Second-Generation Optune® System. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Skin toxicities associated with tumor treating fields: case based review. [2018]