Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent Grade III Malignant Astrocytoma
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|ClinicalTrials.gov Identifier: NCT03450850|
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : June 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Astrocytoma, Grade III||Device: NOVOTTF-200A||Not Applicable|
The primary objective will be to determine the efficacy of NOVOTTF-200A in recurrent anaplastic astrocytoma patients (6-month progression-free survival)
- 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)
- 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 (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Single Arm Study Of NOVOTTF-200A In Bevacizumab-Naive Subjects With Recurrent WHO Grade III Malignant Astrocytoma|
|Actual Study Start Date :||May 21, 2020|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
NOVOTTF-200A treatment in Bevacizumab-Naïve Subjects with Recurrent WHO Grade III Malignant Astrocytoma
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.
- Number of participants showing no evidence of disease progression six months after initiating treatment with the device. [ Time Frame: 6 months ]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.
- Evaluation of the safety of NOVOTTF-200A in this subject population. [ Time Frame: 1 year ]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".
- Does the treatment significantly modify the patient's 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 ]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.
- Correlations with established molecular markers (ATRX, TERT promoter and/or IDH1 mutation and MGMT promoter methylation [ Time Frame: Will be assessed at screening and at end of treatment visit, an average of 24 months ]To see if the presence of ATRX, TERT promoter, IDH1 mutations and/or MGMT promoter methylation, confers a better response to NOVOTTF-200A.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450850
|Contact: Daniela Bota, MD||1-877-UC-STUDYfirstname.lastname@example.org|
|United States, California|
|University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Principal Investigator:||Daniela Bota, MD||UC Irvine Health|