Imaging Study of the Distribution of IL13-PE38QQR Infused Before and After Surgery in Adult Patients With Recurrent Malignant Glioma
Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
About this trial
This is an interventional treatment trial for Malignant Glioma focused on measuring CNS neoplasms, Brain neoplasms, neurosurgery, intralesional infusion, recombinant proteins, immunotoxins
Eligibility Criteria
DISEASE CHARACTERISTICS Archival tumor sample must express IL13Rα2 by immuno-histochemistry (IHC) analysis Must have prior histologic diagnosis of supratentorial malignant glioma (Grade 3 or 4), including glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, or mixed oligoastrocytoma (excludes glioma of unknown grade). Patients with clinical/radiographic diagnosis of malignant glioma may be registered pending histologic confirmation. Must have undergone prior surgical resection and received external beam radiotherapy with at least 48 Gy tumor dose, completed at least 8 weeks prior to study Must have recurrent or progressive supratentorial malignant glioma compared with a previous diagnostic study Baseline tumor measured within 2 weeks prior to study entry Stereotactic biopsy at study entry must confirm the presence of glioma (malignant, unless previously documented) Recurrent or progressive tumor must have a solid contrast-enhancing region at least 1.0 cm and no more than 5.0 cm in maximum diameter. One satellite lesion is permitted if separated by 3 cm or less from the primary mass. PATIENT CHARACTERISTICS Age 18 and over Karnofsky Performance Score of at least 70 Absolute neutrophil count at least 1500/mm^3 Hemoglobin at least 10 gm/dL Platelet count at least 100,000/mm^3 PT and aPTT within institutional limit of normal Must be candidate for re-operation Must have recovered from toxicity of prior therapy. Minimum intervals required: at least 6 months after approved intratumoral chemotherapy (e.g. carmustine wafer), at least 6 weeks after nitrosourea-containing chemotherapy, at least 4 weeks after any investigational agent or any other cytotoxic chemotherapy, at least 2 weeks after vincristine or non-cytotoxic chemotherapy Must practice an effective method of birth control during the study Must understand the investigational nature of this study and its potential risks and benefits, and sign an approved written informed consent prior to performance of any study-specific procedure No patients with tumor crossing the midline (tumor involving corpus callosum is permitted if not crossing midline), more than two foci of tumor, or non-parenchymal tumor dissemination (e.g. subependymal or leptomeningeal) No patients with impending herniation (e.g. midline shift greater than 1.0 cm), uncontrolled seizures, or requirement for immediate palliative treatment No patients who have received localized therapy for glioma, e.g. focal single-fraction radiotherapy, brachytherapy, or intracerebral infusion of chemotherapy or cytotoxin No patients who are receiving any concurrent chemotherapy or any other investigational agent (corticosteroids are permitted) No patients with a known allergy to iodine or to contrast medium that may be utilized in scans required by this protocol Female patients must not be pregnant or breast-feeding No patients unwilling or unable to follow protocol requirements
Sites / Locations
- Duke University Medical Center