NOVOTTF-200A for Astrocytoma

Overseen By Daniela Bota, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Daniela A. Bota

Must not be taking: Immunosuppressive agents

Disqualifiers: Pregnancy, Active infection, Other malignancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called NOVOTTF-200A, a medical device, for individuals with Grade III Anaplastic Astrocytoma, a type of brain cancer. Researchers seek to determine if this treatment can benefit patients whose cancer has worsened despite previous treatments and who have not yet tried certain other drugs. Suitable candidates for this trial include those diagnosed with this specific cancer type who have experienced progression after initial treatments. As an unphased trial, this study provides patients the opportunity to explore a potentially beneficial treatment option not yet widely available.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that certain medications, like immunosuppressive agents, may interfere with the study results. You should discuss your current medications with the study team to see if any adjustments are needed.

What prior data suggests that the NOVOTTF-200A device is safe for treating astrocytoma?

Research has shown that NOVOTTF-200A is generally safe. In a study with children, Tumor Treating Fields (TTFields) therapy, which includes NOVOTTF-200A, mostly caused mild to moderate skin issues, such as irritation, with no unexpected side effects. Another study examined over 25,000 patients with brain and spinal cord cancers and found that most tolerated TTFields well. These findings suggest that the treatment is generally safe, with manageable side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for recurrent WHO Grade III malignant astrocytoma, which often involve chemotherapy and radiation, NOVOTTF-200A offers a novel approach by using electric fields to target tumor cells. This treatment, known as Tumor Treating Fields (TTFields), disrupts cancer cell division and growth without the need for invasive procedures or systemic drugs. Researchers are excited about NOVOTTF-200A because it has the potential to minimize side effects typically associated with chemotherapy and radiation, and it can be used in patients who have not previously been treated with bevacizumab, offering a new option for this challenging condition.

What evidence suggests that NOVOTTF-200A is effective for astrocytoma?

Research shows that the NOVOTTF-200A treatment uses electric fields to stop cancer cells from dividing, differing from traditional methods. This approach has shown promise in treating astrocytoma, a type of brain cancer. Earlier studies have linked Tumor Treating Fields (TTFields), like NOVOTTF-200A, to better survival rates. Specifically, when TTFields were combined with chemotherapy, 43% of patients survived for two years, compared to 31% with chemotherapy alone. The treatment is generally well-tolerated, with mostly mild to moderate skin reactions reported. These findings suggest that NOVOTTF-200A could be an effective option for patients with recurring anaplastic astrocytoma. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniela Bota, MD

Principal Investigator

UC Irvine Health

Are You a Good Fit for This Trial?

Adults over 18 with Grade III Anaplastic Astrocytoma who have seen their cancer progress despite earlier treatments, but haven't used Bevacizumab or similar drugs. They should be relatively healthy otherwise, with stable vital signs and blood counts within specific ranges, and able to perform daily activities without significant assistance.

Inclusion Criteria

I have not been treated with BEV or drugs that stop new blood vessels from forming.

It's been over 4 weeks since my surgery and 12 weeks since my last radiotherapy, or I have confirmed relapse.

All my side effects from previous cancer treatments are mild now.

Exclusion Criteria

Any comorbid condition that confounds the ability to interpret data from the study as judged by the Investigator

I am not taking any medication that could affect the study, except for corticosteroids.

I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NOVOTTF-200A treatment. Quality of life assessments using FACT questionnaires are conducted at baseline and every two cycles.

24 months

Visits every two cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of disease progression and molecular marker correlations.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• NOVOTTF-200A

Trial Overview The trial is testing NOVOTTF-200A in patients who haven't been treated with Bevacizumab before. It's a Phase 2 study focusing on those whose cancer has worsened after initial therapies. The goal is to see how effective this treatment is for recurrent malignant astrocytoma.

How Is the Trial Designed?

Group I: NOVOTTF-200A Experimental Treatment 1 Intervention

NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma

Who Is Running the Clinical Trial?

Daniela A. Bota

Lead Sponsor

Trials

1

Recruited

30+

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03450850

NCT03450850 | Study Of NOVOTTF-200A In Bevacizumab ... Primary Objective: The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month ...

2. withpower.com withpower.com/trial/phase-astrocytoma-4-2020-7dafd

NOVOTTF-200A for Astrocytoma · Info for Participants NOVOTTF-200A is a unique treatment for astrocytoma because it uses electric fields to disrupt cancer cell division, unlike traditional treatments that rely on ...

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

Safety of Tumor Treating Fields (TTFields) therapy in pediatric ... Data presented here suggest a favorable safety profile for TTFields therapy, with predominantly mild to moderate localized skin AEs and no unexpected toxicities ...

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

Recent advances in Tumor Treating Fields (TTFields) therapy ... The study also showed this was a long-term benefit: the 2-year survival rate was 43% (TTFields/TMZ) versus 31% (TMZ alone), and 5-year survival ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/11795549251315579

Concurrent Tumor-Treating Fields and Chemoradiotherapy Among the 39 enrolled patients, disease progression was observed in 22 individuals (56.4%), with a median progression-free survival (PFS) of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03450850?tab=results

Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. link.springer.com link.springer.com/article/10.1007/s11060-024-04682-7

Global post‑marketing safety surveillance of Tumor ... This long-term, real-world analysis of > 25,000 patients demonstrated good tolerability of TTFields in patients with CNS malignancies. Most ...