Title A prospective phase II trial of NovoTTF-100A with Bevacizumab (Avastin) in Patients with Recurrent Glioblastoma
IRB CASE 3313
Hospital Main Campus
Phase Phase 2
Disease Brain, Glioblastoma
- To determine the efficacy of the combination of bevacizumab and NovoTTF-100A in bevacizumab-naive patients with recurrent GBM as measured by 6-month progression-free survival (PFS6)
- To assess safety and tolerability of the combination of bevacizumab and NovoTTF-100A in this population
- To evaluate overall survival in this population
- To determine objective response rate (ORR) by modified RANO criteria in this population
- To assess time-to-progression in this population
- To assess neurocognitive outcome and quality of life in this population
- Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
- Patients with up to two prior recurrences are allowed.
- Karnofsky performance status ≥ 70.
- Age ≥ 22 years old.
- Patients must have the following laboratory values:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- Hemoglobin (Hgb) > 9 g/dL
- Serum total bilirubin le;1.5 x ULN
- ALT and AST ≤ 3.0 x ULN
- Serum creatinine ≤ 1.5 x ULN
- Blood coagulation parameters: INR ≤ 1.5
- Minimum interval since completion of radiation treatment is 12 weeks
- Minimum interval since last drug therapy
- 3 weeks since last non-cytotoxic therapy
- 3 weeks must have elapsed since the completion of a non-nitrosourea-containing chemotherapy regimen
- 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen.
- Patients who have had previous treatment either with bevacizumab and or NovoTTF 100A system.
- Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
- Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- History or presence of serious uncontrolled ventricular arrhythmias
- Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE)
- Uncontrolled hypertension (defined by a SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg while on anti-hypertensive medications)
- Patients with cirrhosis, or active viral or nonviral hepatitis.
- Implanted pacemaker,shunts, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
- Infra-tentorial tumor
- Evidence of increased intracranial pressure (clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
- Known sensitivity to conductive hydrogels
- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
- Pregnant or breast-feeding women
- Patients unwilling or unable to comply with the protocol
- Patients with leptomeningeal disease