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Device

NOVOTTF-200A for Astrocytoma

N/A

Waitlist Available

Led By Daniela Bota, MD

Research Sponsored by Daniela A. Bota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females of age ≥18 years at the time of the signing of the informed consent document

No prior treatment with BEV or any anti-angiogenesis agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new drug for brain cancer that has progressed during first or second line treatment.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the specific side effects of NOVOTTF-200A are not listed here, such treatments can commonly cause skin irritation where the device is applied, headaches, malaise, and potentially interfere with wound healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

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My tests show high-grade meningioma with signs it's growing or coming back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants showing no evidence of disease progression six months after initiating treatment with the device.

Secondary outcome measures

Correlations with established molecular markers (ATRX, TERT promoter and/or IDH1 mutation and MGMT promoter methylation

Does the treatment significantly modify the patient's quality of life?

Evaluation of the safety of NOVOTTF-200A in this subject population.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NOVOTTF-200AExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Daniela A. BotaLead Sponsor

NovoCure Ltd.Industry Sponsor

57 Previous Clinical Trials

4,688 Total Patients Enrolled

1 Trials studying Astrocytoma

1 Patients Enrolled for Astrocytoma

Daniela Bota, MDPrincipal InvestigatorUC Irvine Health

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications still being accepted for this research trial?

"Evidently, this clinical trial is still open for participation. As per the latest entries on clinicaltrials.gov, it was initially posted on May 21st 2020 and has been updated as recently as February 19th 2021."

Answered by AI

What is the enrollment capacity of this clinical trial?

"Affirmative, the details published on clinicaltrials.gov verifies that this research is currently seeking participants. Originally posted on May 21st 2020 and most recently revised on February 19th 2021, the study needs to recruit 34 patients from 1 medical center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma

Daniela A. Bota 2020. "Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03450850.