IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma
- Conditions
- Brain and Central Nervous System Tumors
- Registration Number
- NCT00003842
- Lead Sponsor
- Barrett Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of Southern California, Healthcare Consultation Center
🇺🇸Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Neuro-Oncology Service
🇺🇸San Francisco, California, United States
St. Louis University Health Sciences Center
🇺🇸Saint Louis, Missouri, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Charlotte Neurosurgical Associates
🇺🇸Charlotte, North Carolina, United States
Food and Drug Administration
🇺🇸Rockville, Maryland, United States
Laboratory of Molecular Biology
🇺🇸Bethesda, Maryland, United States