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Sponsored by: |
Neopharm |
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Information provided by: | Neopharm |
ClinicalTrials.gov Identifier: | NCT00024570 |
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13 receptor-positive tumor cell lines indicating that it may show a therapeutic benefit. In reciprocal competition experiments, the interaction between IL13-PE38QQR and the IL13 receptors was shown to be highly specific for human glioma cells.
IL13-PE38QQR will be infused in two courses of 96 hours each, eight weeks apart, directly into the malignant brain tumors of patients to determine the dose of drug these patients can tolerate. After that, the selected dose will be studied to give an estimate of the response rate, response duration, time to response, and survival after infusing that dose of IL13-PE38QQR into the recurrent malignant glioma.
Condition | Intervention | Phase |
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Malignant Glioma Glioblastoma Multiforme Anaplastic Astrocytoma Mixed Oligoastrocytoma |
Drug: IL13-PE38QQR Procedure: targeted fusion protein therapy Procedure: surgery |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study |
Estimated Enrollment: | 60 |
Study Start Date: | November 2000 |
OBJECTIVES:
I. Determine the toxicities and maximum tolerated dose of IL13-PE38QQR delivered by continuous infusion into malignant glioma over 96 hours, in two courses eight weeks apart.
II. Estimate the response rate, response duration, time to response, and survival after interstitial infusion of IL13-PE38QQR into recurrent malignant glioma.
III. Describe the toxicities of interstitial infusion of IL13-PE38QQR at the selected dose.
PROTOCOL OUTLINE: Patients are expected to receive two IL13-PE38QQR infusions at 8-week intervals. For each course, drug will be infused through each of two catheters; infusion rate will be held constant during a 96-hour infusion.
In Phase I, the dose of IL13-PE38QQR will be increased by increasing the IL13-PE38QQR concentration in stepwise fashion, while holding infusion volume and duration constant. Three patients will be treated at each dose level until the maximum tolerated dose (MTD) is reached, and an additional three patients are treated at that level. In Phase II, patients will be treated at the selected MTD.
PROJECTED ACCRUAL: In Phase I, up to 30 patients will be treated. In Phase II, up to 35 patients will be treated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Disease Characteristics
Patient Characteristics
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States | |
United States, Florida | |
H. Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
The Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Michigan | |
Henry Ford Health Systems | |
Detroit, Michigan, United States, 48202 | |
United States, North Carolina | |
Wake Forest University | |
Winston Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States |
Study Chair: | Jon Weingart, MD | The Johns Hopkins University |
Study ID Numbers: | IL13PEI-001, NCI-NABTT-9903, JHU-NABTT-9903 |
Study First Received: | September 20, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00024570 |
Health Authority: | United States: Food and Drug Administration |
neurosurgery, craniotomy convection-enhanced delivery CNS interstitial infusion recombinant toxins |
malignant glioma, recurrent catheter, stereotaxic intratumoral therapy positive pressure microinfusion |
Neuroectodermal Tumors Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |