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.
Brain and Central Nervous System Tumors
Biological: interleukin-4 PE38KDEL cytotoxin
Drug: isolated perfusion
Procedure: surgical procedure
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||March 1999|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003842
|United States, California|
|University of Southern California, Healthcare Consultation Center|
|Los Angeles, California, United States, 90033|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94115-0128|
|San Francisco, California, United States, 94143-0372|
|John Wayne Cancer Institute|
|Santa Monica, California, United States, 90404|
|United States, Maryland|
|Laboratory of Molecular Biology|
|Bethesda, Maryland, United States, 20892|
|Food and Drug Administration|
|Rockville, Maryland, United States, 20857|
|United States, Missouri|
|St. Louis University Health Sciences Center|
|Saint Louis, Missouri, United States, 63110-0250|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Charlotte Neurosurgical Associates|
|Charlotte, North Carolina, United States, 28207-1830|
|United States, Ohio|
|Barrett Cancer Center, The University Hospital|
|Cincinnati, Ohio, United States, 45219|
|Study Chair:||Ronald E. Warnick, MD||Barrett Cancer Center|