Pilot Imaging Study to Assess the Distribution of IL13-PE38QQR Cytotoxin Infusions in Patients With Recurrent, Resectable, Supratentorial Malignant Glioma

Inclusion 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