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Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer
This study is currently recruiting participants.
Verified by Eisai Inc., October 2009
First Received: September 4, 2007   Last Updated: October 14, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Eight neurocognitive assessments will be used to assess the primary objective of evaluating the preservation of neurocognitive function over time. [ Time Frame: One year or until the patient has evidence of neurological deterioration due to CNS metastasis, has a local recurrence, withdraws, dies, is lost to follow-up, or the study is closed. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Magnetic resonance imaging (MRI) will be used to assess local recurrence rate of metastatic brain tumors. [ Time Frame: One year or until the patient has evidence of neurological deterioration due to CNS metastasis, has a local recurrence, withdraws, dies, is lost to follow-up, or the study is closed. ] [ Designated as safety issue: No ]
  • Evaluate correlative science in metastatic lesions to the brain using tumor samples. [ Time Frame: One year. ] [ Designated as safety issue: No ]
  • Determine the rate of neurological death defined as death attributable to the progression of neurological disease. [ Time Frame: One year or until the patient has evidence of neurological deterioration due to CNS metastasis, has a local recurrence, withdraws, dies, is lost to follow-up, or the study is closed. ] [ Designated as safety issue: No ]
  • Determine the clinical significance of locally recurrent brain metastasis at the time of their occurrence (mass effect, cognitive functioning other symptoms) post treatment. [ Time Frame: One year or until the patient has evidence of neurological deterioration due to CNS metastasis, has a local recurrence, withdraws, dies, is lost to follow-up, or the study is closed. ] [ Designated as safety issue: No ]
  • Determine the time to and severity of neurocognitive decline. [ Time Frame: One year or until the patient has evidence of neurological deterioration due to CNS metastasis, has a local recurrence, withdraws, dies, is lost to follow-up, or the study is closed. ] [ Designated as safety issue: No ]

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
Criteria

Inclusion Criteria:

  1. Can provide signed/dated Informed Consent, and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
  2. Are a male or female patient 18 years of age or older.
  3. Are willing to a use barrier method of contraception if fertile or of childbearing potential until 30 days after surgical resection. If the patient receives subsequent chemotherapy during study participation (as allowed by the protocol), appropriate contraception will be managed by the principal investigator.
  4. 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.

  5. Have a life expectancy of ≥12 weeks.
  6. Have a Karnofsky Performance Status (KPS) score of 70 or higher.
  7. Have Recursive Partitioning Analysis (RPA) status of 1 or 2.
  8. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of the surgical resection; and
  9. Patients must be able to understand English, either orally or in writing, and be able to consent and complete the required assessments and procedures.

Exclusion Criteria:

  1. Are unable or unwilling to understand study assessment or to cooperate with the study procedures as determined by the investigator.
  2. Have a history of allergic reaction or known hypersensitivity to BCNU (carmustine) or other components of the GLIADEL, such as polifeprosan polymer.
  3. Have a history of prior cranial irradiation.
  4. Have a prior diagnosis of Central Nervous System (CNS) tumor.
  5. Have received prior treatment for brain tumors.
  6. Have had prior exposure to GLIADEL or its components, such as polifeprosan polymer.
  7. Have any uncontrolled medical or psychiatric conditions which preclude them from participating in or completing the study procedures.
  8. Concurrent severe medical conditions include, but are not limited to, active infection, acute hepatitis, cardiac arrhythmia, unstable angina, congestive heart failure, uncontrolled diabetes mellitus, uncontrolled seizures, pulmonary insufficiency, pulmonary fibrosis, pulmonary embolus, etc.
  9. Have a diagnosis of tumor in the brain stem or posterior fossa.
  10. Have an RPA status of 3.
  11. Have a diagnosis of leptomeningeal disease at time of enrollment; or
  12. Are currently pregnant or lactating, or plan to become pregnant during the course of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525590

Contacts
Contact: Eisai Medical Services 1-888-422-4743

Locations
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            
Sponsors and Collaborators
Eisai Inc.
  More Information

No publications provided

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

Keywords provided by Eisai Inc.:
Gliadel

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 27, 2009