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
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.
Interventional
Primary Purpose: Treatment
Ronald E. Warnick, MD
Study Chair
Barrett Cancer Center
United States: Federal Government
CDR0000067001
NCT00003842
March 1999
Name | Location |
---|---|
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
John Wayne Cancer Institute | Santa Monica, California 90404 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
Laboratory of Molecular Biology | Bethesda, Maryland 20892 |
University of Southern California, Healthcare Consultation Center | Los Angeles, California 90033 |
Neuro-Oncology Service | San Francisco, California 94143-0372 |
Food and Drug Administration | Rockville, Maryland 20857 |
Charlotte Neurosurgical Associates | Charlotte, North Carolina 28207-1830 |