Status:
COMPLETED
Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)
Lead Sponsor:
NovoCure Ltd.
Conditions:
Recurrent Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ch...
Detailed Description
PAST CLINICAL EXPERIENCE: The effect of the electric fields generated by the NovoTTF-100A device (TTFields) has been tested in two pilot trials in humans. The data from these trials suggest NovoTTF-1...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT00379470
Start Date
September 1 2006
End Date
January 1 2011
Last Update
May 1 2012
Active Locations (25)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Illinois in Chicago
Chicago, Illinois, United States, 60612
3
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
4
Boston University Medical Center
Boston, Massachusetts, United States, 02118