Evaluating Therapeutic Response to Novo-TTF

Más betegség

• Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other implanted electronic devices in the brain, or documented clinically significant arrhythmias
• History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.

Laborértékek

• Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
  • Thrombocytopenia (platelet count less than 100 x 1000 per microlitre)
  • Neutropenia (absolute neutrophil count less than 1.5 x 1000 per microlitre)
  • 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 greater than 1.7 mg/dL)

Egyéb

• Actively participating in another clinical treatment trial
• Pregnant
• Infra-tentorial tumor
• Evidence of increased intracranial pressure (midline shift 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)

• Newly diagnosed or recurrent GBMs
• Received maximal debulking surgery and radiotherapy (protons or photons) concomitant with Temozolomide (40-75Gy)
• Patients may enroll in the study if received Gliadel wafers before entering the trial.
• Minimal dose for concomitant radiotherapy is 40 Gy
• Karnofsky scale of 60 or greater
• Life expectancy at least 3 months
• Must sign written informed consent
• Treatment start date at least 4 weeks out from surgery or as soon as skin healing/radiation reaction allows
• Measurable enhancing neoplasm on post contrast T1 weighted images and/or non enhancing FLAIR signal abnormality