Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study

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.