TTFields for Brain Cancer

Recruiting at 1 trial location

Overseen By Demetrius Lee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Pregnancy, Active implanted devices, others

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

Approved in 7 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

155 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets individuals with Glioblastoma (GBM), a type of brain cancer, who are beginning treatment with Optune, a device that uses electrical fields to combat cancer cells. Researchers aim to determine if a new, more precise brain scan can improve the setup of the Optune device on the head, potentially enhancing treatment effectiveness. Participants will have their treatment arranged using either standard scans or advanced scans that provide a clearer view of the tumor. This trial suits those who have undergone surgery and radiation for GBM and can use the Optune device. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve treatment effectiveness for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have significant co-morbidities that prevent maintenance TMZ treatment, which suggests that some medications might be allowed. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this technique is safe for glioblastoma patients?

Research has shown that Tumor Treating Fields (TTFields) are generally safe for use. Studies have found that patients, especially those with newly diagnosed glioblastoma, tolerate TTFields well. This noninvasive treatment does not involve surgery or entering the body.

Most patients do not experience severe side effects. Some may have mild skin irritation where the device touches the scalp, but this is usually easy to manage. These studies have reported no serious problems directly linked to TTFields, which is reassuring for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TTFields for Brain Cancer trial because it explores a novel way to personalize treatment for brain cancer patients. Unlike traditional methods that use standard MR imaging for array mapping, this trial is testing an advanced MR imaging technique to guide the placement of TTFields, a type of therapy using electric fields to disrupt cancer cell division. By tailoring the array layout specifically to each patient's tumor characteristics, the trial aims to enhance the effectiveness of TTFields, potentially leading to better outcomes than current standard care, which typically relies on more generalized approaches.

What evidence suggests that this trial's treatments could be effective for glioblastoma?

Research has shown that Tumor Treating Fields (TTFields) can effectively slow the growth of glioblastoma, an aggressive brain cancer. TTFields use low-intensity electric fields to prevent cancer cells from dividing and spreading. Large studies at multiple centers have demonstrated that TTFields can extend the lives of patients with glioblastoma. In this trial, participants will be assigned to one of two arms: one using a conventional array mapping layout based on standard MR imaging sequences, and the other using an advanced MR imaging array mapping layout. The study investigates whether advanced MRI techniques for mapping the treatment area can enhance the effectiveness of TTFields by better targeting the cancer. The goal is to determine if this precise mapping can lead to more cancer cell death and improve survival rates. ^{1 2 3 5 6}

Who Is on the Research Team?

Suyash Mohan, MD

Principal Investigator

University of Pennsylvania

Sanjeev Chawla, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 22 with a confirmed diagnosis of Glioblastoma (GBM) who've had surgery and radiation therapy. They must have good blood, liver, and kidney function and be willing to receive TTFields treatment. It's not for those with GBM below the cerebellum, pregnant women, people with certain medical devices or skull defects, or sensitivity to conductive hydrogels.

Inclusion Criteria

I am 22 years old or older.

My diagnosis of brain cancer is confirmed by lab tests.

My blood, liver, and kidney functions are all within normal ranges.

Exclusion Criteria

My brain tumor is located below the tentorium.

Active implanted medical device, a skull defect (such as missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts, other implanted electronic devices in the brain

I have bleeding in the area of my tumor that could affect imaging tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Optune with either standard or alternative array mapping based on MRI techniques

2 months

Regular visits for treatment monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

Clinical follow-ups at regular intervals

What Are the Treatments Tested in This Trial?

Interventions

• WBSI Guided Personalized Delivery of TTFields

Trial Overview The study tests if an advanced MRI technique called 'whole brain spectroscopy' can better guide the placement of TTFields therapy compared to standard mapping. This could potentially improve survival rates and quality of life by more effectively targeting tumor cells in GBM patients.

How Is the Trial Designed?

Group I: Advanced MR Imaging Array Mapping Layout Experimental Treatment 1 Intervention

Participants in this study arm will receive Optune array layout mapping created from advanced MR imaging sequences obtained through trial enrollment.

Group II: Conventional Array Mapping Layout Active Control 1 Intervention

Participants in this study arm will still receive Optune array layout mapping based on standard MR imaging sequences.

WBSI Guided Personalized Delivery of TTFields is already approved in United States, European Union, Canada, Japan, China 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 Canada as Optune for:

• Newly diagnosed glioblastoma
• Recurrent glioblastoma

Approved in Japan as Optune for:

• Newly diagnosed glioblastoma
• Recurrent glioblastoma

Approved in China as Optune for:

• Newly diagnosed glioblastoma
• Recurrent glioblastoma

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

NovoCure Ltd.

Industry Sponsor

Trials

64

Recruited

6,100+

Ashley Cordova

NovoCure Ltd.

Chief Executive Officer

Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel

Uri Weinberg

NovoCure Ltd.

Chief Medical Officer since 2020

MD from an unspecified institution

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a study of 91 patients with primary IDH wild-type glioblastoma, those who used tumor treating fields (TTFields) for 2 or more months with over 75% compliance showed improved overall survival, highlighting the potential efficacy of TTFields in this treatment context.

TTFields usage was significantly associated with overall survival, independent of other factors like surgical resection extent and MGMT methylation status, suggesting that consistent use of TTFields may enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of tumor treating field usage in patients with primary glioblastoma: A single institutional experience. Ballo, MT., Qualls, KW., Michael, LM., et al.[2022]

The study systematically evaluated how the positioning of electrode arrays for tumor treating fields (TTFields) affects the treatment of glioblastoma, identifying two optimal array positions for various tumor locations based on a realistic human head model.

An oblique layout of the arrays, oriented at 45 degrees to the sagittal plane, was found to be more effective than traditional configurations, suggesting it could improve treatment efficacy for most frontoparietal tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of electrode position for the distribution of tumor treating fields (TTFields) in a human brain. Identification of effective layouts through systematic analysis of array positions for multiple tumor locations. Korshoej, AR., Hansen, FL., Mikic, N., et al.[2019]

Tumor Treating Fields (TTFields) significantly reduced the size and proliferation of glioblastoma microtumors in patient-derived three-dimensional tissue cultures, indicating their efficacy in targeting tumor growth.

The study highlights the variability in response to TTFields among different patient samples, suggesting that these pre-clinical models can help predict individual treatment responses and explore the underlying mechanisms of resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glioblastoma-Derived Three-Dimensional Ex Vivo Models to Evaluate Effects and Efficacy of Tumor Treating Fields (TTFields). Nickl, V., Schulz, E., Salvador, E., et al.[2022]

A new optimization method for tumor treating fields (TTFields) allows for individual adjustment of device settings to achieve desired field intensity in glioblastoma tumors while minimizing unwanted spatial correlations, which can enhance treatment efficacy.

Using finite element methods based on MRI data from a glioblastoma patient, the algorithm successfully reduced fractional anisotropy of the electric fields in the tumor, potentially improving the delivery of therapeutic currents without compromising overall intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of tumor treating fields using singular value decomposition and minimization of field anisotropy. Korshoej, AR., Sørensen, JCH., von Oettingen, G., et al.[2020]

Tumor Treating Fields (TTFields) significantly reduced pancreatic cancer cell counts and increased abnormal mitotic figures in both in vitro and in vivo models, indicating its potential as an effective antimitotic treatment.

When combined with chemotherapy, TTFields enhanced tumor volume reduction in a hamster model of pancreatic cancer, suggesting a synergistic effect that could improve treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Giladi, M., Schneiderman, RS., Porat, Y., et al.[2022]

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]

Tumor treating fields (TTFields) are a novel treatment that uses low-intensity electric fields to disrupt cell division and organelle assembly, showing promise in various tumor types.

In phase 3 trials for glioblastoma, TTFields combined with standard chemotherapy (temozolomide) significantly prolonged progression-free survival and overall survival, indicating its efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor treating fields: a novel treatment modality and its use in brain tumors. Hottinger, AF., Pacheco, P., Stupp, R.[2022]

Tumor Treating Fields (TTFields) therapy is a noninvasive treatment approved by the FDA for recurrent and newly diagnosed glioblastoma, which disrupts cancer cell division and may stimulate immune responses, potentially improving patient outcomes.

TTFields therapy offers a promising alternative to traditional treatments like chemotherapy, as it not only aims to prolong survival but also enhances the quality of life for patients with this aggressive form of brain cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Clinical Application of Tumor Treating Fields Therapy in Glioblastoma. Riley, MM., San, P., Lok, E., et al.[2020]

Optimizing the placement of intracranial electrodes for tumor treating fields (TTF) can significantly enhance electric field strengths, achieving growth arrest in 98-100% of tumor volumes in high-grade glioma cases with minimal current (0.54-0.64 A).

This targeted approach to TTF therapy may offer a substantial survival benefit for patients with brain tumors located in difficult-to-reach areas, potentially changing the treatment landscape for brain cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling of intracranial tumor treating fields for the treatment of complex high-grade gliomas. Segar, DJ., Bernstock, JD., Arnaout, O., et al.[2023]

In a study of 428 newly diagnosed glioblastoma patients from the EF-14 trial, tumor-treating fields (TTFields) were shown to influence the location and patterns of tumor progression, with distant lesions appearing further from the primary tumor in patients treated with TTFields compared to controls.

Higher doses of TTFields were associated with improved clinical outcomes, suggesting that optimizing the placement of TTFields arrays can enhance treatment efficacy by targeting areas at higher risk of tumor progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Tumor Treating Fields on Glioblastoma Progression Patterns. Glas, M., Ballo, MT., Bomzon, Z., et al.[2022]

Tumor-Treating Fields (TTFields) demonstrated improved clinical efficacy and a good safety profile in treating glioblastoma, with median overall survival of 21.7 months for newly diagnosed cases and 10.3 months for recurrent cases based on a meta-analysis of 20 studies involving 1636 patients.

Compliance with TTFields treatment of 75% or more was linked to better overall survival, and while dermatologic side effects were common, they were manageable, supporting TTFields as a viable addition to standard treatment protocols for glioblastoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor-Treating Fields for the treatment of glioblastoma: a systematic review and meta-analysis. Regev, O., Merkin, V., Blumenthal, DT., et al.[2022]

Tumor treating fields (TTFields) therapy shows heterogeneous distribution of electric fields in the pelvis and abdomen, which is influenced by the shape and location of the clinical target volumes (CTVs) and surrounding anatomical structures.

The study utilized advanced imaging and modeling techniques to create a personalized evaluation method for TTFields therapy in ovarian carcinoma, highlighting the importance of patient-specific factors in optimizing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Treating Fields for Ovarian Carcinoma: A Modeling Study. Lok, E., San, P., White, V., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05086497

WBSI Guided Personalized Delivery of TTFields This study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05086497?cond=%22Glioblastoma%20multiforme%22&viewType=Table&rank=8

WBSI Guided Personalized Delivery of TTFields It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

3. withpower.com withpower.com/trial/phase-brain-neoplasms-2022-f3036

TTFields for Brain Cancer Research shows that Tumor Treating Fields (TTFields) can effectively slow down tumor growth in glioblastoma (a type of brain cancer) by using low-intensity ...

4. 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.

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

Recent advances in Tumor Treating Fields (TTFields) therapy ... This article comprehensively reviews the mechanism, efficacy, safety, and quality of life of Tumor Treating Fields (TTFields) therapy in glioblastoma.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12487835/

Tumor Treating Fields: An Innovative Therapy for ... In this review, we will describe TTFields therapy mechanisms of action, available efficacy and safety data in glioblastoma, administration and ...