Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer
Condition: Metastatic Brain Cancer
MeSH terms: Brain Neoplasms
Intervention: GLIADEL
Intervention description: 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.
Intervention MeSH terms: Carmustine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gliadel

Summary:

      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.
    

Eligibility 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.