Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00525590
First received: September 4, 2007
Last updated: July 10, 2014
Last verified: July 2014
  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 2

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

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 ]

Enrollment: 69
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525590

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
Sponsors and Collaborators
Eisai Inc.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Gliadel

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 22, 2014