A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma
NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.
• 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.
• Patients must have the following laboratory values:
‣ Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L
⁃ Platelets ≥ 100 x 10\^9/L
⁃ Hemoglobin (Hgb) \> 9 g/dL
⁃ Serum total bilirubin: ≤ 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 must have signed an approved informed consent and authorization permitting release of personal health information.
• Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effects of bevacizumab on developing fetus or nursing infant are not known. Female patients of child-bearing potential must have a negative pregnancy test.
• Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ three years.
• Patients must be maintained on a stable corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment.