Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas
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|ClinicalTrials.gov Identifier: NCT02507232|
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Device: NovoTTF-200A Drug: Temozolomide||Early Phase 1|
Approximately 2,000 to 3,000 low-grade gliomas (LGGs) are diagnosed in adults each year in the United States. Based on a variety of prognostic factors the median overall survival ranges from 3 to 9 years.
NovoTTF-200A is a device that produces alternating electrical fields within the human body that disrupt cell division. These very low intensity intermediate frequency electric fields (TTFields) impair the growth of tumor cells through the arrest of cell division and inducing apoptosis.
Although FDA approved for the treatment of recurrent or progressive glioblastoma, further investigation of NovoTTF-200A is warranted, in the setting of low-grade glioma where it has the potential to stunt tumor growth without significant toxicity. NovoTTF-200A has also been shown to be safe combined with adjuvant 5-day temozolomide regimen in newly diagnosed glioblastoma in an ongoing clinical trial. Given the low proliferative index in low-grade gliomas, combining NovoTTF-200A with metronomic chemotherapy may be more effective.
This is a randomized, 2-arm, open label study of NovoTTF-200A alone or combined with daily temozolomide for the treatment of patients with newly diagnosed low-grade gliomas.
Patients will be randomized 1:1 to one of two arms for a total of 22 patients (11 per arm). Arm A will receive NovoTTF-200A only and Arm B will receive NovoTTF-200A and low-dose (50 mg/m2) daily temozolomide regimen.
All patients providing informed consent will be screened for eligibility. Baseline assessments will include vital signs, physical exam, blood hematology and chemistries, Karnofsky Performance Status (KPS) evaluation, Quality of Life (QOL) assessment using the Functional Assessment of Cancer Therapy-Brain (FACT-Br), a neurological exam and neuro-imaging (MRI) of brain. An extra blood sample will be collected for biomarker studies.
Clinical evaluations include physical exam, vitals, KPS, neurological exam and blood hematology and chemistries (obtained once every month throughout treatment). Neuro-imaging and assessment for response will be performed approximately every 3 months. QOL will be assessed with the KPS rating scale and the FACT-Br questionnaire at screening and then every six months during treatment. Blood will be collected for correlative studies on Day 1 of every even cycle. Any molecular information derived from the correlative studies or clinical care will be associated with the patient's response.
Patients will continue monthly cycles of treatment for 12 cycles or until disease progression or unacceptable toxicity (whichever occurs first). For those in Arm B, patients may continue NovoTTF-200A treatment if temozolomide is discontinued early for toxicity. An end of treatment visit for clinical evaluations and safety assessments will be performed approximately four to six weeks of withdrawing from study treatment. Patients discontinuing study treatment will be followed at months 18 and 24 with tumor assessments if they discontinued from study treatment without disease progression and for survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Randomized Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas|
|Actual Study Start Date :||April 17, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2022|
Active Comparator: Arm A
Active Comparator: Arm B
NovoTTF-200A + Temozolomide 50 mg/m2 daily (oral)
50 mg/m2/day rounded to the nearest 5 mg. One cycle is 28 days and will be given for 12 cycles
Other Name: Temodar
- Toxicity associated with treatment with NovoTTF-200A alone and combined with temozolomide [ Time Frame: 24 months ]Participants will be assessed for the development of toxicity according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.03. Dose adjustments will be made according to the system showing the greatest degree of toxicity.
- Efficacy of NovoTTF-200A alone and combined with temozolomide [ Time Frame: 24 months ]Participants will be assessed for efficacy of NovoTTF-200A alone and combined with temozolomide as measured by progression free survival (PFS), overall survival (OS), and tumor responses over 24 months.
- 12-month objective response rate (ORR) of NovoTTF-200A alone and combined with temozolomide [ Time Frame: 12 months ]Participants will be assessed for 12-month objective response rate (ORR) of NovoTTF-200A alone and combined with temozolomide in the treatment of adults with newly diagnosed low grade glioma.
- Effects of NovoTTF-200A alone and combined with temozolomide on seizure activity [ Time Frame: 24 months ]Participants will be assessed for seizure frequency.
- Effects of NovoTTF-200A alone and combined with temozolomide on quality of life (QOL) [ Time Frame: 24 months ]Participants will be assessed for quality of life using the FACT-Br questionnaire.
- Frequency of transformation from low-grade glioma into high-grade glioma [ Time Frame: 24 months ]Glioma tumor grade will be assessed over time for transformation to a higher grade.
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): NCT02507232
|Contact: Jaya Gill, RNfirstname.lastname@example.org|
|Contact: Neuro-Oncology Teamemail@example.com|
|United States, California|
|John Wayne Cancer Institute||Recruiting|
|Santa Monica, California, United States, 90404|
|Principal Investigator:||Santosh Kesari, MD, PhD||John Wayned Cacner Institute|