IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma
IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma
RATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without
 harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma.

 PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in
 treating patients who have recurrent malignant astrocytoma.
OBJECTIVES: I. Determine the maximum tolerated dose of intratumorally infused
 IL-4(38-37)-PE38KDEL immunotoxin in patients with recurrent malignant astrocytoma. II.
 Determine the safety of this regimen in these patients. III. Determine preliminarily any
 efficacy of this regimen in these patients.

 OUTLINE: This is a dose escalation, multicenter study. Patients undergo a stereotactic biopsy
 under MR/CT guidance. Catheters are then placed into the tumor under stereotactic guidance.
 The catheter is filled with IL-4(38-37)-PE38KDEL immunotoxin (IL-4 toxin), with infusion
 beginning 24 hours after catheter insertion. The IL-4 toxin is infused over 4 days. The
 catheter is removed 45 minutes after the infusion is completed and a MR scan is performed.
 Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated
 dose (MTD) is reached. The MTD is defined as the dose preceding the dose at which 2 of 3
 patients experience dose limiting toxicity. Patients are followed every 4 weeks for 16 weeks,
 then every 8 weeks for up to 3 years.

 PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically proven recurrent glioblastoma or anaplastic
 astrocytoma Stereotactically accessible, enhancing mass no greater than 50 mL total volume
 by MRI No significant mass effect Recent craniotomy allowed No anaplastic oligodendroglioma
 No tumors of the brainstem, cerebellum, or both hemispheres No diffuse subependymal or CSF
 disease If on stable or increasing dose of steroid, must have evidence of increasing
 contrast enhancement by MRI or CT scan Prior external beam radiotherapy required

 PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life
 expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3
 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9.5 g/dL Hepatic: Bilirubin
 less than 2 mg/dL AST and ALT less than 2 times upper limit of normal (ULN) PT/PTT no
 greater than ULN Renal: Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy
 test Fertile patients must use effective contraception No systemic diseases to cause
 unacceptable anesthetic/operative risk No active infection requiring treatment No
 unexplained febrile illness

 PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent blood or platelet transfusions
 Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease
 Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior
 radiotherapy Surgery: See Disease Characteristics Medically able to undergo surgery Other:
 No other concurrent investigational agents