Post-approval Study of NovoTTF-100A in Recurrent GBM Patients

Stopped early · Phase 4

Conditions studied: Recurrent Glioblastoma Multiforme

In brief

This is a non-randomized, concurrent control study, designed to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings following approval is comparable to that of BSC chemotherapy patients. The device is a portable, battery operated device that was approved for the treatment of adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

Key facts

Study ID

NCT01756729

Run by

NovoCure Ltd.

People needed

13

Starts

2012-12-01

Expected to finish

2018-01-01

Last updated by the study team

2016-03-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 22 years of age or older
• Histological diagnosis of GBM (WHO grade IV)
• Tumor located in the supra-tentorial region of the brain
• Received maximal, safe, surgical resection
• Received maximal radiation therapy
• Received concomitant Temozolomide
• Received maintenance Temozolomide
• First recurrence (based on radiological or histological evidence of recurrence)
• Karnofsky performance score 70 or above
• MMSE score 25 or above
• Adequate amount and quality of tumor tissue from first surgical resection available for genetic profiling
• Women of childbearing age must be on effective contraception
• Signed informed consent
• Stable steroid dose in past 4 weeks

You may not qualify if…

• Implanted electronic medical device in the brain:
• Deep brain stimulator
• Vagus nerve stimulator
• Programmable shunt
• Skull defect without replacement
• Unable to comply with treatment with the NovoTTF-100A device
• Pregnant
• Prior antiangiogenic therapy (e.g., Bevacizumab/Avastin)
• Second or subsequent recurrence
• Any prior cytotoxic chemotherapy except Temozolomide
• Actively participating in another therapeutic clinical trial
• Radiological suspicion of pseudoprogression or radionecrosis
• Radiation therapy or surgery in the past 4 weeks
• Unable to comply with the study follow-up schedule
• Any serious co-morbidity which is expected to affect survival more adversely than GBM

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Barrow Neurology Clinics — Phoenix, Arizona, United States
• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• University of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States
• Washington University School of Medicine, Division of Oncology — St Louis, Missouri, United States
• The Long Island Brain Tumor Center — Lake Success, New York, United States
• Geisinger Health System — Danville, Pennsylvania, United States
• Baylor Research Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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