Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)

Completed · Phase 3

Conditions studied: Glioblastoma Multiforme

In brief

The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

Key facts

Study ID

NCT00916409

Run by

NovoCure Ltd.

People needed

700

Starts

2009-06-01

Expected to finish

2017-03-01

Last updated by the study team

2017-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathological evidence of GBM using WHO classification criteria.
• > 18 years of age.
• Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):
• Patients may enroll in the study if received Gliadel wafers before entering the trial
• Any additional treatments received prior to enrollment will be considered an exclusion.
• Minimal dose for concomitant radiotherapy is 45 Gy
• Karnofsky scale ≥ 70
• Life expectancy at least 3 months
• Participants of childbearing age must use effective contraception.
• All patients must sign written informed consent.
• Treatment start date at least 4 weeks out from surgery.
• Treatment start date at least 4 weeks out but not more than 7 weeks from the later of last dose of concomitant Temozolomide or radiotherapy.

You may not qualify if…

• Progressive disease (according to MacDonald Criteria). If pseudoprogression is suspected, additional imaging studies must be performed to rule out true progression.
• Actively participating in another clinical treatment trial
• Pregnant
• Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
• Thrombocytopenia (platelet count < 100 x 103/μL)
• Neutropenia (absolute neutrophil count < 1.5 x 103/μL)
• CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
• Significant liver function impairment - AST or ALT > 3 times the upper limit of normal
• Total bilirubin > upper limit of normal
• Significant renal impairment (serum creatinine > 1.7 mg/dL)
• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias.
• Infra-tentorial tumor
• Evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.

Where it is running

• Barrow Neurology Clinics — Phoenix, Arizona, United States
• City of Hope — Duarte, California, United States
• University of California San Diego Moores Cancer Center (UCSD) — La Jolla, California, United States
• University of Southern California (USC) — Los Angeles, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• UF Health Cancer Center at Orlando Health — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Emory University, Winship Cancer Institute — Atlanta, Georgia, United States
• University of Illinois at Chicago (UIC) — Chicago, Illinois, United States
• University of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Maine Medical Center — Scarborough, Maine, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine, Division of Oncology — St Louis, Missouri, United States
• New Jersey Neuroscience Center - JFK Medical Center — Edison, New Jersey, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Weill Cornell Medical College — New York, New York, United States
• Mount Sinai Medical Center, Department of Neurosurgery — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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