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

Astrocytoma, Grade III Clinical Trial

Official title: Phase II, Single Arm Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent WHO Grade III Malignant Astrocytoma

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Primary Objective:

The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month progression-free survival)

Secondary Objectives:

• To evaluate the safety of NOVOTTF-200A in the subject population.

• To evaluate efficacy of NOVOTTF-200A in the subject population.

• To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.

• To determine if the treatment significantly modifies the patient's quality of life. Sponsor will use the Functional Assessment of Cancer Therapy (FACT) questionnaires:

• FACT-Brain (FACT-Br)

• FACT-Cognitive Function (FACT-Cog)

Exploratory Objectives:

• To determine if the presence of proneural or mesenchymal phenotype (Cytoscan analysis) confers a better response to NovoTTF.

• To determine if the in vitro sensitivity of the glioma cells derived from patient specimens before and after the NOVOTTF-200A treatment correlates with the patient's response to treatment. ;

Related Conditions & MeSH terms

• Astrocytoma
• Astrocytoma, Grade III

• NCT number: NCT03450850
• Study type: Interventional
• Source: University of California, Irvine
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 21, 2020
• Completion date: September 2024