The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme

Inclusion Criteria: Patients must be ≥ 18 years old. Patients must have clinical and/or radiographic evidence of FIRST recurrence or progression of supratentorial GBM afer a previous resection or biopsy and external beam radiation therapy. Patients must have histopathologic documentation of GBM at initial diagnosis. Patients must have had previous cytoreductive surgery or biopsy for GBM. Patients must have received external beam radiotherapy with ≥ 45 Gy tumor dose, completed ≥ 4 weeks prior to study entry. Gross total resection (i.e., ≥ 95% resection of the solid, contrast-enhancing tumor component) must be planned. Tumor must have a solid contrast-enhancing component ≥ 1.0 cm in diameter. Baseline measurements must be obtained ≤ 2 weeks prior to study entry. Patients must be in adequate condition, as indicated by: Karnofsky Performance Score ≥ 70, Adequate hematologic status: i. Absolute neutrophil count (ANC) ≥ 1,500/mm3; ii. Hemoglobin ≥ 10 gm/dL; iii. Platelets ≥ 100,000/mm3; iv. PT and aPTT ≤ 1.5 x institutional upper limit Patients must not be receiving concurrent anti-tumor therapy and must have recovered from toxicity of prior therapy. Minimum intervals required: ≥ 6 weeks after receiving nitrosourea cytotoxic drug ≥ 4 weeks after receiving any non-nitrosourea cytotoxic drug or any systemic investigational agent ≥ 2 weeks after receiving any non-cytotoxic anti-tumor drug (including celecoxib or other drugs, if they are being used as anti-tumor therapies) Patients must be willing to practice an effective method of birth control during the study. Female patients must not be pregnant or breast-feeding. Patients or legal representative must understand the investigational nature of this study and sign a written informed consent form, approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC), prior to performance of any study-specific procedure Exclusion Criteria: Patients with contrast-enhancing tumor component crossing the midline, multi-focal tumor not amenable to gross total resection, or tumor dissemination (subependymal or leptomeningeal). Expected communication between ventricle and resection cavity that cannot be repaired in order to safely use GLIADEL® Wafer. Patients with clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment. Patients who have received any type of stereotactic radiosurgery or brachytherapy, with the exception of the stereotactic radiosurgery boost part of the initial fractionated external beam radiation therapy. Patients who have received: 1) prior treatment with IL13-PE38QQR, or, 2) GLIADEL® Wafer, or, 3) any intracerebral investigational agent Patients who have demonstrated a previous hypersensitivity to BCNU or any other component of the GLIADEL® Wafer. Patients unwilling or unable to follow protocol requirements.