Trial Outcomes & Findings for HUMC 1612: Optune NovoTTF-200A System (NCT NCT03128047)

Last Updated: 2025-07-08

Results Overview

Number of participants receiving treatment with the Optune NovoTTF-200A System with treatment-related adverse events as assessed by CTCAE v4.0.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

56 Days

Results posted on

2025-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Recurrent High Grade Gliomas and Ependymomas Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Recurrent High Grade Gliomas and Ependymomas Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

HUMC 1612: Optune NovoTTF-200A System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recurrent High Grade Gliomas and Ependymomas n=7 Participants Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Age, Categorical <=18 years	6 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.4 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 56 Days

Population: Number of patients with device related adverse events

Number of participants receiving treatment with the Optune NovoTTF-200A System with treatment-related adverse events as assessed by CTCAE v4.0.

Outcome measures

Outcome measures
Measure	Recurrent High Grade Gliomas and Ependymomas n=6 Participants Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Safety of the Optune NovoTTF-200A System When Used Alone in Pediatric Patients With Recurrent High-grade Gliomas.	0 Participants

PRIMARY outcome

Timeframe: 56 Days

Population: Number of patients who found the device tolerable

Number of participants receiving treatment with the Optune NovoTTF-200A System with who return tolerability questionnaire and found the device tolerable

Outcome measures

Outcome measures
Measure	Recurrent High Grade Gliomas and Ependymomas n=6 Participants Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Tolerability of the Optune NovoTTF-200A System When Used Alone in Pediatric Patients With Recurrent High-grade Gliomas.	6 Participants

SECONDARY outcome

Timeframe: Up to 2 years after study entry

Number of patients who are progression-free. Disease progression is defined as 25% or more increase in the product of perpendicular diameters of ANY target lesion, taking as reference the smallest product observed since the start of treatment (see exception below), OR the appearance of one or more new lesions, OR worsening neurologic status not explained by causes unrelated to tumor progression (e.g., anticonvulsant or corticosteroid toxicity, electrolyte disturbances, sepsis, hyperglycemia, presumed post-therapy swelling etc.) PLUS any increase in tumor cross-sectional area (or tumor volume).

Outcome measures

Outcome measures
Measure	Recurrent High Grade Gliomas and Ependymomas n=6 Participants Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Assess the Progression Free of Patients Treated on This Study Protocol to Aid in the Future Development of Pediatric Phase II/III Studies Using the Optune NovoTTF-200A System.	1 Participants

SECONDARY outcome

Timeframe: Up to 2 years after study entry

Population: Number of patients who were alive at 2 years post study entry

Number of patients who were alive at 2 years post study entry

Outcome measures

Outcome measures
Measure	Recurrent High Grade Gliomas and Ependymomas n=6 Participants Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Assess the Overall Survival of Patients Treated on This Study Protocol to Aid in the Future Development of Pediatric Phase II/III Studies Using the Optune NovoTTF-200A System.	1 Participants

Adverse Events

Recurrent High Grade Gliomas and Ependymomas

Serious events: 3 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Recurrent High Grade Gliomas and Ependymomas n=6 participants at risk Recurrent high-grade glioma and ependamoma patients will receive treatment with the Optune NovoTTF-200A system as monotherapy. Interventions: Device: Optune NovoTTF-200A System Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab. Optune NovoTTF-200A System: Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
Cardiac disorders Hypertension	50.0% 3/6 • Number of events 6 • For 30 days after participants stopped wearing the device, up to 2 years.
Renal and urinary disorders Proteinuria	16.7% 1/6 • Number of events 1 • For 30 days after participants stopped wearing the device, up to 2 years.
Immune system disorders Allergic reaction to drug	16.7% 1/6 • Number of events 1 • For 30 days after participants stopped wearing the device, up to 2 years.
Skin and subcutaneous tissue disorders Surgical site Wound	16.7% 1/6 • Number of events 1 • For 30 days after participants stopped wearing the device, up to 2 years.

Other adverse events

Adverse event data not reported

Additional Information

Jeanette Haugh

Hackensack Meridian Health

Phone: 5519963457

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place