NovoTTF Systems for Spinal Cancer

Overseen By Claudio Tatsui, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Targeted therapy

Disqualifiers: Psychiatric illness, Cognitive limitation, Pacemaker, Pregnant, Dermatological conditions, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of two devices, NovoTTF-200M and NovoTTF-200A, for treating spinal cancer unresponsive to previous treatments. The study examines the effectiveness of these devices alone or in combination with standard treatments. Participants should have spinal tumors previously treated with surgery or radiation, with no further radiation options available. Those with cancers such as lung, breast, or prostate affecting the spine may be suitable candidates, particularly if tumors are located between the neck and lower back. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the NovoTTF Systems are safe for spinal cancer patients?

Studies have shown that the NovoTTF-200A device is already used to treat certain brain tumors, like glioblastoma, and is generally safe for patients. The device sends electric fields to stop tumor cells from growing. Research suggests that this method remains safe even with other electronic devices implanted in the body.

For the NovoTTF-200M, early studies are still exploring its safety for spinal tumors. Similar technology is used for other types of cancer and has received approval in some cases. This provides some confidence in its potential safety, but more research is needed for confirmation.

Both treatments involve wearing a device that sends low-level electric fields to the tumor area. This method is non-invasive and does not require surgery. Existing data shows that patients usually tolerate this approach well. However, since this trial is in an early phase, more testing is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NovoTTF-200A and NovoTTF-200M for spinal cancer because they offer a novel approach using electric fields to disrupt cancer cell division, unlike traditional treatments such as surgery, radiation, or chemotherapy. These devices work by delivering Tumor Treating Fields (TTFs), which are low-intensity, alternating electric fields that specifically target cancer cells without harming healthy ones. This unique mechanism not only minimizes side effects but also allows for continuous treatment, which could potentially improve outcomes for patients with fewer interruptions to their daily lives.

What evidence suggests that the NovoTTF Systems could be effective for spinal cancer?

Research has shown that the NovoTTF-200A and NovoTTF-200M devices, studied in this trial, use tumor-treating fields (TTFields) to slow cancer cell growth. Studies have found that TTFields can help control tumor growth and improve outcomes for cancer patients. In an early study with 30 patients, the tumor did not grow for about 9.3 months on average, and patients lived for about 15.8 months after starting treatment. Additionally, 66% of patients lived for at least one year after beginning treatment. These results suggest that the NovoTTF systems may effectively manage cancer that hasn't responded to other treatments. ^{1 4 6 7 8}

Who Is on the Research Team?

Claudio Tatsui, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with spinal cancer that has spread and hasn't responded to treatment. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have a specific type of tumor.

Inclusion Criteria

Women of child-bearing potential must agree prior to study entry to use adequate contraception for the duration of study participation.

Patients must have the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device.

For the non-surgical group only, expected survival of more than 8 months as confirmed by the primary oncologist.

Exclusion Criteria

Physical or cognitive limitation that prevents the ability to independently disconnect the arrays or turn off the system if they feel uncomfortably hot while using the device.

Psychiatric illness/social situations that would limit compliance with study requirements.

History of allergic reactions or sensitivity to conductive hydrogels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the NovoTTF-200M or Novo TTF-200A systems, alone or in combination with standard therapy

12 months

Regular visits every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• NovoTTF-200A
• NovoTTF-200M

Trial Overview The study is testing the safety of two systems, NovoTTF-200M and Novo TTF-200A, used alone or with standard therapy in treating stubborn spinal tumors. It's an early-phase trial focused on how well patients tolerate these treatments.

How Is the Trial Designed?

Group I: Treatment with 150 KHZ (NovoTTF-200M) or 200KHZ (NovoTTF-200A) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK602919/

Optune (NovoTTF-200A) - NCBI Bookshelf Optune is a medical device that produces alternating electrical fields called tumour-treating fields (TTFields) to target growth of cancerous cells in addition ...

2. app.trialscreen.org app.trialscreen.org/trials/phase-1-novottf-200m-novo-ttf-200a-systems-treatment-refractory-spinal-trial-nct06906900

A Phase I Study of the NovoTTF-200M and Novo TTF-200A ... The study treatment, TTFields, represents a new approach to cancer treatment that may be effective in controlling tumor growth and improving outcomes. Risks ...

3. withpower.com withpower.com/trial/novottf-systems-for-spinal-cancer-26c38

NovoTTF Systems for Spinal Cancer This Phase 1 medical study run by M.D. Anderson Cancer Center is evaluating whether NovoTTF-200A and NovoTTF-200M will have tolerable side effects ...

4. clinconnect.io clinconnect.io/trials/NCT06906900

A Phase I Study of the NovoTTF-200M and Novo TTF-200A The study aims to find out how well these devices work on their own or when used alongside standard treatment, especially for patients whose tumors have not ...

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. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1441146/full

Case report: Safety of Tumor Treating Fields therapy with ... This report suggests that TTFields therapy concomitant with an implanted electronic device may be safe in patients with GBM.

7. insight.jci.org insight.jci.org/articles/view/176962

Tumor treating fields suppress tumor cell growth and ... Our data suggest that TTFields can be leveraged as a local therapy within minimally conductive bone of spinal metastases.

8. ldh.la.gov ldh.la.gov/assets/Medicaid/MCPP/12_10_24/1824_LHCC_LA.CP.MP.145_Electric_Tumor_Treating_Fields_Optune_12.24.pdf

Clinical Policy: Electric Tumor Treating Fields (Optune) The device is worn throughout the day and attached to the head by electrodes which creates a low intensity, alternating electric field within the tumor that ...