Details

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

Description

  1. 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

Inclusion Criteria

  1. Pathological evidence of GBM using WHO classification criteria.
  2. ≥ 18 years of age
  3. Received maximal debulking surgery and radiotherapy concomitant with Temozolomide (45-70Gy):
    1. Patients may enroll in the study if received Gliadel wafers before entering the trial
    2. Any additional treatments received prior to enrollment will be considered an exclusion.
    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.
Exclusion Criteria

Exclusion Criteria

  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
  3. Pregnant
  4. Significant co-morbidities at baseline which would prevent maintenance Temozolomide treatment:
    1. Thrombocytopenia (platelet count < 100 x 10^3/mL)
    2. Neutropenia (absolute neutrophil count < 1.5 x 10^3/mL)
    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 normal
    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 arrhythmias.
  6. Infra-tentorial tumor
  7. Evidence of increased intracranial pressure (midline shift > 5 mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
  8. History of hypersensitivity reaction to Temozolomide or a history of hypersensitivity to DTIC.