TTFields for Brain Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sanjeev Chawla, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Pregnancy, Active implanted devices, others

No Placebo Group

Approved in 7 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is for Glioblastoma (GBM) patients who will be beginning Optune as part of their clinical care, which is a novel treatment that utilizes - tumor treating fields (TTFields), (aka, electrical therapy), which has shown to improve overall survival in large multi-center trials. As a part of this study, participants will either receive Optune with "standard array mapping" (based on regular contrast enhanced MRI) or an "alternative (more precise) array mapping" based on sophisticated state of the art MRI techniques including "whole brain spectroscopy". Whole brain MRI spectroscopy provides additional metabolic information to map out the full extent of tumor spreading within the brain (far beyond from what is seen on regular MRI), by identifying certain metabolites that are present in cancer cells versus healthy tissue. This study is being performed to show whether alternative array mapping improves treatment outcomes, as opposed to the standard array mapping, by maximizing delivery of TTFields dose, thereby achieving more effective tumor cell killing, decreasing the rate of local recurrence, and improving the overall survival as well as quality of life measures.

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 data supports the effectiveness of the treatment 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 electric fields. Studies have demonstrated that TTFields can reduce tumor size and the number of actively dividing cancer cells, suggesting its potential as a beneficial treatment for brain cancer. ^{1 2 3 4 5}

Is TTFields treatment safe for humans?

Studies show that Tumor Treating Fields (TTFields) have a good safety profile, especially in newly diagnosed glioblastoma patients. The treatment is noninvasive and has been approved by the FDA, indicating it is generally safe for human use. ^{1 5 6 7 8}

How is the TTFields treatment different from other treatments for brain cancer?

TTFields is unique because it uses low-intensity, alternating electric fields to disrupt cancer cell division, unlike traditional treatments like chemotherapy or radiation. This non-invasive approach specifically targets tumor cells without affecting healthy cells, offering a novel way to treat brain cancer. ^{1 9 10 11 12}

Research Team

Suyash Mohan, MD

Principal Investigator

University of Pennsylvania

Sanjeev Chawla, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• WBSI Guided Personalized Delivery of TTFields (Electrical Therapy)

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.

Participant Groups

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 Canada, Japan, China for the following indications:

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+

Dr. Robert H. Vonderheide

Abramson Cancer Center of the University of Pennsylvania

Chief Executive Officer since 2017

DPhil in Immunology from Oxford University, MD from Harvard Medical School

Dr. Lawrence N. Shulman

Abramson Cancer Center of the University of Pennsylvania

Chief Medical Officer since 2017

MD from Harvard Medical School

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Dr. Robert H. Vonderheide

Abramson Cancer Center at Penn Medicine

Chief Executive Officer since 2017

MD from Harvard Medical School

Dr. Bonnie Ky

Abramson Cancer Center at Penn Medicine

Chief Medical Officer

MD, MSCE from University of Pennsylvania

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+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

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]

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]

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]

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]

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) 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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Glioblastoma-Derived Three-Dimensional Ex Vivo Models to Evaluate Effects and Efficacy of Tumor Treating Fields (TTFields). [2022]

2. United States 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Optimization of tumor treating fields using singular value decomposition and minimization of field anisotropy. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Modeling of intracranial tumor treating fields for the treatment of complex high-grade gliomas. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Tumor-Treating Fields for the treatment of glioblastoma: a systematic review and meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Tumor treating fields: a novel treatment modality and its use in brain tumors. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Determinants of tumor treating field usage in patients with primary glioblastoma: A single institutional experience. [2022]

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

The Clinical Application of Tumor Treating Fields Therapy in Glioblastoma. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. [2022]

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

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

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

Tumor Treating Fields for Ovarian Carcinoma: A Modeling Study. [2022]

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

The Impact of Tumor Treating Fields on Glioblastoma Progression Patterns. [2022]