LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases

Overview

RATIONALE: LMB-7 immunotoxin can locate tumor cells and kill them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of LMB-7 immunotoxin in treating patients who have leptomeningeal metastases metastases.

OBJECTIVES: I. Determine the toxicity of intrathecal LMB-7 immunotoxin in patients with leptomeningeal metastases. II. Identify objective therapeutic responses in this group of patients. OUTLINE: This is a dose escalation study. Patients receive LMB-7 intrathecally on days 1, 3, and 5. Treatment may be repeated every 4 weeks if the patient does not demonstrate HAMA neutralizing antibodies to PE-38 in CSF, has stable or responding disease, and has not experienced greater than grade II toxicity. Three to six patients are entered at each dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience grade 3 or worse toxicity or a neuroradiology toxicity score of 10 or greater. PROJECTED ACCRUAL: Approximately 15 to 24 patients will be accrued over one year.

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Eligibility

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