Clinical trial NCT00076986 (phase 3, status: completed)
Conditions: glioblastoma multiforme
ICD codes: L51.0, L51.8, L51.9
Drugs: il13-pe38qqr, prolifespan 20 with carmustine implant (gliadel® wafer)
SMILES: ClCCNC(=O)N(CCCl)N=O
Eligibility criteria:

        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:

               1. Karnofsky Performance Score ≥ 70,

               2. 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.