Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically proven malignant glioma (grade 3 or 4) - Anaplastic astrocytoma.

• - Glioblastoma multiforme.

• - Malignant mixed oligoastrocytoma.

• - Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study.

• - Must have undergone supratentorial brain tumor surgery or biopsy.

• - Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study.

• - Must have solid portion measuring 1.0-5.0 cm in maximum diameter.

• - Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm.

• - No tumor crossing the midline.

• - No leptomeningeal tumor dissemination.

• - No impending herniation or spinal cord compression.

• - No uncontrolled seizures.

PATIENT CHARACTERISTICS: Age:

• - 18 and over.

Performance status:

• - Karnofsky 60-100% Life expectancy: - Not specified.

Hematopoietic:

• - Absolute neutrophil count at least 1,500/mm^3.

• - Hemoglobin at least 10 g/dL.

• - Platelet count at least 100,000/mm^3.

Hepatic:

• - PT and PTT no greater than upper limit of normal (ULN) - SGOT and SGPT no greater than 2.5 times ULN.

• - Bilirubin no greater than 2.0 mg/dL.

Renal:

• - Not specified.

Other:

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception.

• - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer.

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - Not specified.

Chemotherapy:

• - No prior intralesional chemotherapy for malignant glioma.

• - At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered.

• - No concurrent chemotherapy.

Endocrine therapy:

• - Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study.

Radiotherapy:

• - See Disease Characteristics.

• - No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma.

Surgery:

• - See Disease Characteristics.

Other:

• - Recovered from any prior therapy.

- No other concurrent investigational agent

OBJECTIVES:

• - Determine the toxic effects and maximum tolerated dose (MTD) of interstitial interleukin-13 PE38QQR immunotoxin in patients with malignant glioma.

• - Determine the response rate, duration of response, time to response, overall survival, and time to progression in patients treated with this regimen.

• - Determine the toxic effects of this drug at the MTD in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter placement on day 56 and then receive a second interstitial infusion beginning on day 57 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for phase I of the study within 6 months and a total of 12-35 patients will be accrued for phase II of the study within 10-12 months.