IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma
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|ClinicalTrials.gov Identifier: NCT00003842|
Recruitment Status : Unknown
Verified June 1999 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 14, 2004
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Biological: interleukin-4 PE38KDEL cytotoxin Drug: isolated perfusion Procedure: surgical procedure||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|