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|NCT00916409 : Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)|
|Ages||Min: 18 Years Max: N/A|
1. Pathological evidence of GBM using WHO classification criteria.
2. > 18 years of age.
3. Received maximal debulking surgery and radiotherapy concomitant with Temozolomide
1. Patients may enroll in the study if received Gliadel wafers before entering the
2. Any additional treatments received prior to enrollment will be considered an
3. Minimal dose for concomitant radiotherapy is 45 Gy
4. Karnofsky scale ? 70
5. Life expectancy at least 3 months
6. Participants of childbearing age must use effective contraception.
7. All patients must sign written informed consent.
8. Treatment start date at least 4 weeks out from surgery.
9. 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.
1. Progressive disease (according to MacDonald Criteria). If pseudoprogression is
suspected, additional imaging studies must be performed to rule out true progression.
2. Actively participating in another clinical treatment trial
4. Significant co-morbidities at baseline which would prevent maintenance Temozolomide
1. Thrombocytopenia (platelet count < 100 x 103/?L)
2. Neutropenia (absolute neutrophil count < 1.5 x 103/?L)
3. CTC grade 4 non-hematological Toxicity (except for alopecia, nausea, vomiting)
4. Significant liver function impairment - AST or ALT > 3 times the upper limit of
5. Total bilirubin > upper limit of normal
6. Significant renal impairment (serum creatinine > 1.7 mg/dL)
5. Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other
implanted electronic devices in the brain, or documented clinically significant
6. Infra-tentorial tumor
7. Evidence of increased intracranial pressure (midline shift > 5mm, clinically
significant papilledema, vomiting and nausea or reduced level of consciousness)
8. History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00916409
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