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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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: | 75 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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| Contact: Eisai Medical Services | 1-888-422-4743 |
| United States, Arizona | |
| University of Arizona / University Medical Center | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| Contact: Jamie Holt 520-626-6800 jholt1@email.arizona.edu | |
| Principal Investigator: Baldassarre Stea, MD, PhD | |
| United States, California | |
| University of California, Los Angeles | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: RoseMarie Lara 310-267-2621 rlara@mednet.edu | |
| Principal Investigator: Linda Liau, MD | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Shirley Entis 813-745-3929 shirley.entis@moffitt.org | |
| Principal Investigator: Steven Brem, MD | |
| University of South Florida | Recruiting |
| Tampa, Florida, United States, 33606 | |
| Contact: Deborah Scott 813-259-0965 descott@health.usf.edu | |
| Principal Investigator: Harry Van Loveren, MD | |
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Lori Loftis 773-702-4632 lloftis@surgery.bsd.uchicago.edu | |
| Principal Investigator: Maciej Lesniak, MD | |
| NorthShore University HealthSystem Reseach Institute | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Contact: Patricia Lada 847-570-2025 plada@enh.org | |
| Principal Investigator: Nina Paleologos, MD | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Jane Hershberger, RN 319-384-7912 Jane-Hershberger@uiowa.edu | |
| Principal Investigator: John Buatti, MD | |
| United States, New York | |
| Weill Medical College Department of Neurological Surgery | Terminated |
| New York City, New York, United States, 10021 | |
| United States, North Carolina | |
| Carolina Neurosurgery & Spine Associates | Recruiting |
| Charlotte, North Carolina, United States, 28204 | |
| Contact: Peggy Boltes, RN 704-831-4006 peggy.boltes@CNSA.com | |
| Principal Investigator: Anthony Asher, MD | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Lucillle Purser 919-843-7112 lpurser@med.unc.edu | |
| Principal Investigator: Matthew Ewend | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Marci Ciolfi 216-445-3407 Ciolfim@ccf.org | |
| Principal Investigator: Michael Vogelbaum, M.D., Ph.D. | |
| The Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Jill Brown 614-293-5554 Jill.Brown@osumc.edu | |
| Principal Investigator: Herbert Newton, MD | |
| United States, Pennsylvania | |
| Temple University | Recruiting |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Contact: Emerson Clement 215-707-4071 emerson.clement@tuhs.temple.edu | |
| Principal Investigator: Michael Weaver, MD | |
| United States, Tennessee | |
| Methodist University Hospital | Terminated |
| Memphis, Tennessee, United States, 38104 | |
| Vanderbilt | Terminated |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Trinity Mother Frances Neuroscience Institute | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Contact: Kevin Thornton, LVN, CCRC 903-510-8862 thorntk@tmfhs.org | |
| Principal Investigator: Sabatino Bianco, MD | |
| UT Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Stacy Foster, RN 214-648-7031 stacy.foster@utsouthwestern.edu | |
| Principal Investigator: Elizabeth Maher, MD | |
More Information
| Responsible Party: | Eisai Inc. ( Lorraine Hughes, MS ) |
| Study ID Numbers: | GLIA-001 |
| Study First Received: | September 4, 2007 |
| Last Updated: | October 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00525590 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Gliadel |
|
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Carmustine Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Pharmacologic Actions |
Brain Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Nervous System Neoplasms |