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Sponsored by: |
Neopharm |
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Information provided by: | Neopharm |
ClinicalTrials.gov Identifier: | NCT00076986 |
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADEL® Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.
Condition | Intervention | Phase |
---|---|---|
Glioblastoma Multiforme |
Drug: IL13-PE38QQR Procedure: surgery and catheter placement (2 procedures) Drug: prolifespan 20 with carmustine implant (GLIADEL® Wafer) Procedure: surgery and wafer placement (1 procedure) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL® Wafer With Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence |
Estimated Enrollment: | 300 |
Study Start Date: | February 2004 |
PRECISE is a Phase III clinical trial of experimental drug IL13-PE38QQR (Study Drug). IL13-PE38QQR is a tumor-targeting agent administered by a continuous infusion directly into the brain around the cavity where the tumor has been removed. Through previous research, this Study Drug has shown potential to control some of the recurrent malignant gliomas, such as glioblastoma multiforme (GBM), anaplastic astrocytoma, and malignant mixed oligoastrocytoma.
The Study Drug is made by combining a human protein (IL13) with a portion of a bacterial toxin protein, Pseudomonas Exotoxin (PE). The IL13 portion binds to receptors on the tumor like a “key to a lock,” allowing the PE portion to enter and kill those cells. Since tumor cells preferentially bind the drug, normal (healthy) brain cells are much less likely to be damaged by the drug. The Study Drug is delivered through tubing or catheters placed directly into the area surrounding the resection cavity. These catheters will be surgically placed from 2-7 days after the tumor has been removed. A pump is then used to slowly push the drug solution through the catheters using convection-enhanced delivery (CED) over a period of 4 days.
The GLIADEL® Wafer is an anti-cancer drug that is approved by the U.S. Food and Drug Administration (FDA) and sold for the treatment of recurrent or newly diagnosed GBM. Patients receiving GLIADEL® will have wafers placed at the time of surgery to remove tumor.
Eligible patients enrolled in the PRECISE trial will be randomly assigned to receive either IL13-PE38QQR or GLIADEL® Wafer. Patients will have a 2 out of 3 chance to receive IL13-PE38QQR and 1 out of 3 chance to receive GLIADEL® Wafer.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must be in adequate condition, as indicated by:
Exclusion Criteria:
Patients who have received:
1) prior treatment with IL13-PE38QQR, or, 2) GLIADEL® Wafer, or, 3) any intracerebral investigational agent
Study ID Numbers: | IL13PEI-301-R03, PRECISE Trial |
Study First Received: | February 6, 2004 |
Last Updated: | January 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00076986 |
Health Authority: | United States: Food and Drug Administration |
brain tumor recurrent malignant glioma brain neoplasm central nervous system surgery resection GLIADEL |
infusion glioblastoma multiforme convection-enhanced delivery first recurrence recurrent GBM GBM supratentorial GBM |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Carmustine Neuroepithelioma Glioma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Pharmacologic Actions |