Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-02 @ 3:36 PM
Study NCT ID:
NCT02507232
Status:
TERMINATED
Last Update Posted:
2020-07-28
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas
Sponsor:
Santosh Kesari
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label, Randomized Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the effectiveness and safety of the NovoTTF-200A device in patients with low-grade glioma when it's used by itself or used together with temozolomide. Researchers would also like to know whether the use of NovoTTF-200A, with or without temozolomide, is associated with fewer negative side effects on mental function that may be seen with other currently used treatment options.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: