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

September 4, 2007
July 10, 2014
September 2007
December 2010   (final data collection date for primary outcome measure)
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 ]
Eight neurocognitive assessments will be used to assess the primary objective of evaluating the preservation of neurocognitive function over time. [ Time Frame: One year ]
Complete list of historical versions of study NCT00525590 on ClinicalTrials.gov Archive Site
  • 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 ]
  • An MRI will be used to assess local recurrence rate of metastatic brain tumors [ Time Frame: One year ]
  • Evaluate correlative science in metastatic lesions to the brain using tumor samples [ Time Frame: One year ]
  • Determine the rate of neurological death defined as death attributable to the progression of neurological disease [ Time Frame: One year ]
  • 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 ]
  • Determine the time to and severity of neurocognitive decline [ Time Frame: One year ]
Not Provided
Not Provided
 
Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer
A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Brain Cancer
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.
Experimental: 1
Intervention: Drug: GLIADEL
Brem S, Meyers CA, Palmer G, Booth-Jones M, Jain S, Ewend MG. Preservation of neurocognitive function and local control of 1 to 3 brain metastases treated with surgery and carmustine wafers. Cancer. 2013 Nov 1;119(21):3830-8. doi: 10.1002/cncr.28307. Epub 2013 Aug 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
March 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00525590
GLIA-001
Yes
Eisai Inc.
Eisai Inc.
Not Provided
Not Provided
Eisai Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP