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Study of NovoTTF-200A Alone and With Temozolomide in Patients With Low-Grade Gliomas

NCT02507232 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-07-28

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

NovoTTF-200A

12 cycles

DRUG

Temozolomide

50 mg/m2/day rounded to the nearest 5 mg. One cycle is 28 days and will be given for 12 cycles

Sponsors & Collaborators

  • NovoCure Ltd.

    collaborator INDUSTRY

  • Santosh Kesari

    lead OTHER

Principal Investigators

  • Santosh Kesari, MD, PhD · Saint John's Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2020-07-27
Completion
2020-07-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02507232 on ClinicalTrials.gov