Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma

Inclusion Criteria

• •Disease Characteristics
• •Must have had surgery (or biopsy) of a supratentorial brain tumor with pathologic diagnosis of malignant (grade 3 or 4) glioma, including anaplastic astrocytoma, glioblastoma multiforme and malignant mixed oligoastrocytoma. (Note: If diagnosis is dependent upon the Day 0 biopsy, pathology must be confirmed prior to start of IL13PE-38QQR infusion).
• •Must have received cranial radiotherapy, with tumor dose of at least 48 Gy, completed at least 12 weeks prior to study entry.
• •Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with a previous study. The baseline tumor measurements must be determined within 2 weeks prior to study entry. The tumor must have a solid portion at least 1.0 cm but not more than 5.0 cm in maximum diameter. A maximum of one satellite lesion is permitted, if separated by less than 3 cm from the primary mass.
• •Stereotaxic biopsy at study entry must confirm the presence of glioma.
• •Patient Characteristics
• •Age 18 or greater.
• •Karnofsky Performance Score must be at least 60.
• •Hematologic status: Absolute neutrophils at least 1,500/mm\^3; Hemoglobin at least 10 gm/dL; Platelets at least 100,000/mm\^3; PT \& PTT less than or equal to the upper limit of normal.
• •Hepatic Status: Transaminases not more than 2.5 x upper limit of normal; Total Bilirubin not more than 2.0 mg/dL.
• •Must have recovered from toxicity of prior therapy; at least 6 weeks elapsed since receiving nitrosourea-containing chemotherapy and 3 weeks since receiving any other 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 must sign informed consent.
• •No patients with more than two foci of tumor, tumor crossing the midline, or leptomeningeal tumor dissemination.
• •No patients with impending herniation, spinal cord compression, or uncontrolled seizures.
• •No patients who have received any localized antitumor therapy for the malignant glioma, either intralesional chemotherapy or focal radiotherapy (i.e. any form of stereotaxic RT or brachytherapy).
• •No patients who are receiving concurrent chemotherapy or another investigational agent.
• •No patients with prior or concurrent malignancy. (Patients with curatively treated carcinoma-in-situ or basal cell skin carcinoma OR who have been free of disease for at least 5 years are eligible).
• •Female patients must not be pregnant or breast-feeding.