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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by (Responsible Party): | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00525590 |
Purpose
The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers on the neurocognitive functioning in patients with metastatic brain cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Brain Cancer |
Drug: GLIADEL |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer |
| Estimated Enrollment: | 59 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: GLIADEL
Resect the tumor as completely as possible. After repeated irrigation of the decompressed area demonstrates no bleeding, and care is taken not to have any foreign material enter the ventricle, up to 8 GLIADEL wafers should be placed to cover the entire surface area of the resection cavity (if possible). Slight overlapping of wafer edges is permitted. The number of wafers will be determined by the size of the tumor resection cavity. Each GLIADEL wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when 8 wafers are implanted. The GLIADEL wafer is a round white to yellow disk with flat surfaces.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have a primary diagnosis of solid-based tumor cancer (except small cell lung cancer (SCLS), lymphoma, germ cell cancer or anaplastic thyroid cancer) or unknown primary cancer and have 1-3 brain metastasis(es) for which surgical resection is planned for a single metastasis and any remaining metastases are planned for stereotactic radiosurgery (SRS);
OR
an intra-operative diagnosis of metastatic brain tumor in a patient with a single brain lesion.
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| University of Arizona / University Medical Center | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| NorthShore University HealthSystem Reseach Institute | |
| Evanston, Illinois, United States, 60201 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, New York | |
| Weill Medical College Department of Neurological Surgery | |
| New York City, New York, United States, 10021 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Carolina Neurosurgery & Spine Associates | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Temple University | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Tennessee | |
| Methodist University Hospital | |
| Memphis, Tennessee, United States, 38104 | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| UT Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| Trinity Mother Frances Health System | |
| Tyler, Texas, United States, 75702 | |
More Information
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00525590 History of Changes |
| Other Study ID Numbers: | GLIA-001 |
| Study First Received: | September 4, 2007 |
| Last Updated: | October 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Gliadel |
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |