Details
Description
Inclusion Criteria
Exclusion Criteria
Details
Title Prospective, Multi-center Trial of NovoTTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM
IRB NOVO1308
CC 931
Hospital Main Campus
Disease Brain
Drug NovoTTF-100A, Temozolomide
Description
- To compare the efficacy and safety outcome of newly diagnosed GBM patients treated with NovoTTF-100A concomitant to Temozolomide to those treated with Temozolomide alone
Inclusion Criteria
- 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 Criteria
- 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 10^3/mL)
- Neutropenia (absolute neutrophil count < 1.5 x 10^3/mL)
- 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 > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.