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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase 2 study in subjects with WHO Grade III Anaplastic Astrocytoma (G3 astrocytoma) who had progressive disease during first or second line treatment and who have not previously received any BEV or any experimental agents.

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.

How is the NOVOTTF-200A treatment different from other treatments for astrocytoma?

NOVOTTF-200A is a unique treatment for astrocytoma because it uses electric fields to disrupt cancer cell division, unlike traditional treatments that rely on surgery, radiation, or chemotherapy. This non-invasive approach offers a novel mechanism of action compared to standard therapies. ^{1 2 3 4 5}

Research Team

Daniela Bota, MD

Principal Investigator

UC Irvine Health

Eligibility Criteria

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 am 18 years or older and have signed the consent form.

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.

Exclusion Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

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

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Anaplastic Astrocytoma: State of the art and future directions. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Anaplastic astrocytoma. [2018]

3. Germany pubmed.ncbi.nlm.nih.gov

PI3K/AKT pathway alterations are associated with clinically aggressive and histologically anaplastic subsets of pilocytic astrocytoma. [2021]

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

Medical management of high-grade astrocytoma: current and emerging therapies. [2017]

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

A brain-penetrant RAF dimer antagonist for the noncanonical BRAF oncoprotein of pediatric low-grade astrocytomas. [2020]