Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)

Completed · Phase 3

Conditions studied: Recurrent Glioblastoma Multiforme

In brief

The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).

Key facts

Study ID

NCT00379470

Run by

NovoCure Ltd.

People needed

236

Starts

2006-09-01

Expected to finish

2011-01-01

Last updated by the study team

2012-05-01

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.
• Not a candidate for further radiotherapy or additional resection of residual tumor.
• Patients with disease progression (by Macdonald criteria i.e., > 25% or new lesion) documented by CT or MRI within 4 weeks prior to enrollment
• Karnofsky scale ≥ 70
• Life expectancy at least 3 months
• Participants of childbearing age must use effective contraception.
• All patients must sign written informed consent.

You may not qualify if…

• Actively participating in another clinical treatment trial
• Within 4 weeks from surgery for recurrence
• Within 4 weeks from any prior chemotherapy.
• Within 4 weeks from radiation therapy
• Pregnant
• Significant co-morbidities (within 4 weeks prior to enrollment):
• 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)
• Coagulopathy (as evidenced by PT or APTT >1.5 times control in patients not undergoing anticoagulation)
• Thrombocytopenia (platelet count < 100 x 103/μL)
• Neutropenia (absolute neutrophil count < 1 x 103/μL)
• Anemia (Hb < 10 g/L)
• Severe acute infection
• Implanted pacemaker, defibrillator or deep brain stimulator, 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)

Where it is running

• Northwestern University — Chicago, Illinois, United States
• University of Illinois in Chicago — Chicago, Illinois, United States
• Evanston Northwestern Healthcare — Evanston, Illinois, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lahey Clinic Medical Center — Burlington, Massachusetts, United States
• NJ Neuroscience Institute - JFK Medical Center — Edison, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• University Hospital Graz — Graz, Austria
• FN Brno - Masaryk University — Brno, Czechia
• Na Homolce Hospital — Prague, Czechia
• Hospital of Neurology Lyon - University Claude Bernard Lyon 1 — Lyon, France
• Group Hospitals Pitie-Salpetriere — Paris, France
• University Hospital Augsburg — Augsburg, Germany
• University Medical Center Hamburg-Eppendorf — Hamburg, Germany
• University Hospital of Schleswig-Holstein — Kiel, Germany
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland

Full record on ClinicalTrials.gov

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