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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate \>= 75% (\>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
University of California, Irvine
Orange, California, United States
Number of Participants Showing no Evidence of Disease Progression Six Months After Initiating Treatment With the Device.
The primary objective is to estimate the proportion of participants showing no evidence of disease progression six months after initiating treatment with the device. Assessment is per RANO (2010) criteria.
Time frame: 6 months
Number of Participants Who Experience Any Adverse Events Who Received NOVOTTF-200A.
All subjects will be evaluated for safety analysis if they receive NOVOTTF-200A. Safety and tolerability of NOVOTTF-200A treatment will be based on the incidence and severity of adverse events and toxicities. Toxicities will be assessed according to the "Common toxicity criteria (CTC), version 4.03". Refer to the Adverse Events (AEs) section for full list of reported AEs.
Time frame: 1 year
Does the Treatment Significantly Modify the Patient's Quality of Life?
To determine if the treatment significantly modifies the patient's quality of life we will be using the Functional Assessment of Cancer Therapy (FACT) questionnaires that include the FACT-Brain (FACT-Br), and the FACT-Cognitive Function (FACT-Cog) questionnaires. These will be completed at baseline then every two cycles. Scores of FACT-COG and FACT-Br are combined below at baseline and last cycle of treatment. Scores of FACT-COG and FACT-Br are summed to obtain a total possible scale range of 0 to 272. FACT-Cog (using the Cognitive Impairments subscale) with a score range from 0-72 and FACT-Br with a score range from 0-200. A higher score, means a better quality of life.
Time frame: Will be assessed at baseline and every two cycles (at the end of each even-numbered cycle of therapy) until treatment termination, an average of 24 months
Correlations With Established Molecular Markers (ATRX, and/or Mutation and MGMT Promoter Methylation
To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
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Time frame: Assessed at screening.