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.
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.
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
interleukin-4 PE38KDEL cytotoxin, isolated perfusion, surgical procedure
University of Southern California, Healthcare Consultation Center
Los Angeles
California
United States
90033
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:58:31-0400
RATIONALE: Interleukin-4 PE38KDEL cytotoxin may be able to deliver cancer-killing substances directly to solid tumor cells. PURPOSE: Phase I trial to study the effectiveness of intravenou...
Randomised phase 3 trial comparing 2 arms: an experimental treatment (Isolated pelvis perfusion) and a standard treatment (systemic chemotherapy +/- radiotherapy +/- surgery). Patients in...
Minimally-Invasive Isolated Limb Perfusion
The aim is to analyse feasibility of a minimally-invasive isolated limb perfusion.
Isolated Thoracic Perfusion (ITP-F) for MPM
This is an observational study of isolated thoracic perfusion with subsequent hemofiltration to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in mal...
A randomized controlled, open-label, multi-centre study evaluating if Isolated Hepatic Perfusion (IHP) increases Overall Survival compared with Best Alternative Care (BAC) in patients with...
Isolated limb perfusion for locally advanced angiosarcoma in extremities: A multi-centre study.
Angiosarcomas are rare and aggressive soft-tissue sarcomas. The only potential curative treatment is complete surgical excision. This study reports the outcome of isolated limb perfusion (ILP) with hi...
Autoregulation in paediatric TBI-current evidence and implications for treatment.
Children who survive acute traumatic brain injury are at risk of death from subsequent brain swelling and secondary injury. Strict physiologic management in the ICU after traumatic brain injury is bel...
The Fontan procedure [total cavopulmonary connection (TCPC)] is the final palliation for patients with univentricular physiology. We studied differential perfusion ratio and percentage uptake of a rad...
Brain perfusion alterations in Tick-Borne Encephalitis - preliminary report.
Magnetic resonance imaging (MRI) changes in Tick-borne encephalitis (TBE) are nonspecific and pathophysiologic mechanisms leading to their formation remain unclear. This study aimed to investigate bra...
Minimally Invasive, Isolated Tricuspid Valve Redo Surgery: A Safety and Outcome Analysis.
Isolated tricuspid valve (TV) surgery is considered a high risk-procedure. The optimal surgical approach is controversial. We analyzed our experience with isolated TV redo surgery performed either ...
Cerebral Blood Volume
Volume of circulating blood in a region of the brain. It is a functional measure of the brain perfusion status which relates changes in this to changes in CEREBROVASULAR CIRCULATION that are often seen in brain diseases.
Interleukin Receptor Common Gamma Subunit
An interleukin receptor subunit that was originally discovered as a component of the INTERLEUKIN 2 RECEPTOR. It was subsequently found to be a component of several other receptors including the INTERLEUKIN 4 RECEPTOR, the INTERLEUKIN 7 RECEPTOR, the INTERLEUKIN-9 RECEPTOR, the INTERLEUKIN-15 RECEPTOR, and the INTERLEUKIN-21 RECEPTOR. Mutations in the gene for the interleukin common gamma chain have been associated with X-LINKED COMBINED IMMUNODEFICIENCY DISEASES.
Surgical Wound
An incision made during a surgical procedure.
Receptors, Interleukin-13
Cell surface receptors for INTERLEUKIN-13. Included under this heading are the INTERLEUKIN-13 RECEPTOR ALPHA2 which is a monomeric receptor and the INTERLEUKIN-4 RECEPTOR TYPE II which has specificity for both INTERLEUKIN-4 and INTERLEUKIN-13.
Interleukin-12 Subunit P40
A cytokine subunit that is a component of both interleukin-12 and interleukin-23. It binds to the INTERLEUKIN-12 SUBUNIT P35 via a disulfide bond to form interleukin-12 and to INTERLEUKIN-23 SUBUNIT P19 to form interleukin-23.