Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I Study of a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin Termed IL-4(38-37)-PE38KDEL (IL-4 Toxin) for the Treatment of 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.
;
Primary Purpose: Treatment
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