IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma
NCT ID: NCT00003842
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
1999-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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interleukin-4 PE38KDEL cytotoxin
isolated perfusion
surgical procedure
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9.5 g/dL Hepatic: Bilirubin less than 2 mg/dL AST and ALT less than 2 times upper limit of normal (ULN) PT/PTT no greater than ULN Renal: Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No systemic diseases to cause unacceptable anesthetic/operative risk No active infection requiring treatment No unexplained febrile illness
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent blood or platelet transfusions Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Medically able to undergo surgery Other: No other concurrent investigational agents
18 Years
ALL
No
Sponsors
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Barrett Cancer Center
OTHER
Principal Investigators
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Ronald E. Warnick, MD
Role: STUDY_CHAIR
Barrett Cancer Center
Locations
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University of Southern California, Healthcare Consultation Center
Los Angeles, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Neuro-Oncology Service
San Francisco, California, United States
John Wayne Cancer Institute
Santa Monica, California, United States
Laboratory of Molecular Biology
Bethesda, Maryland, United States
Food and Drug Administration
Rockville, Maryland, United States
St. Louis University Health Sciences Center
St Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Charlotte Neurosurgical Associates
Charlotte, North Carolina, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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UCMC-981061
Identifier Type: -
Identifier Source: secondary_id
NBI-3001-9802
Identifier Type: -
Identifier Source: secondary_id
NCI-V99-1536
Identifier Type: -
Identifier Source: secondary_id
CDR0000067001
Identifier Type: -
Identifier Source: org_study_id