Status:
COMPLETED
Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)
Lead Sponsor:
NovoCure Ltd.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 treatm...
Detailed Description
PAST CLINICAL EXPERIENCE: The effect of the electric fields generated by the NovoTTF-100A device (TTFields, TTF) has been tested in a large prospective, randomized trial, in recurrent GBM. The outcom...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2017
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00916409
Start Date
June 1 2009
End Date
March 1 2017
Last Update
April 10 2017
Active Locations (89)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3410
2
Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
3
City of Hope
Duarte, California, United States, 91010-3000
4
University of California San Diego Moores Cancer Center (UCSD)
La Jolla, California, United States, 92093