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

Condition(s) targeted: Metastatic Brain Cancer

Intervention: Gliadel (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eisai Inc.

Overall contact:
Eisai Medical Services, Phone: 1-888-422-4743

The purpose of this study is to determine the effect of the surgical intervention and insertion of GLIADEL wafers in patients with metastatic brain cancer.

Official title: A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Eight neurocognitive assessments will be used to assess the primary objective of evaluating the preservation of neurocognitive function over time.

Secondary outcome:

An MRI will be used to assess local recurrence rate of metastatic brain tumors

Evaluate correlative science in metastatic lesions to the brain using tumor samples

Determine the rate of neurological death defined as death attributable to the progression of neurological disease

Determine the clinical significance of locally recurrent brain metastasis at the time of their occurrence (mass effect, cognitive functioning other symptoms) post treatment

Determine the time to and severity of neurocognitive decline

Detailed description: (Note: This clinical trial was quality controlled by itself, since no protocol was available to Eisai Medical Research Inc.)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 non-small cell lung cancer (NSCLC), breast, melanoma, renal, colon, or unknown primary cancer and have single brain metastasis for which surgical resection is planned;

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.

Eisai Medical Services, Phone: 1-888-422-4743

University of Arizona / University Medical Center, Tucson, Arizona 85724, United States; Recruiting
Jamie Holt, Phone: 520-626-6800, Email: jholt1@email.arizona.edu
Baldassarre Stea, MD, PhD, Principal Investigator

University of California, Los Angeles, Los Angeles, California 90095, United States; Recruiting
Emma Young, Phone: 310-267-2621, Email: elyoung@mednet.ucla.edu
Linda Liau, MD, Principal Investigator

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida 33612, United States; Recruiting
Shirley Entis, Phone: 813-745-3929, Email: shirley.entis@moffitt.org
Steven Brem, MD, Principal Investigator

University of South Florida, Tampa, Florida 33606, United States; Recruiting
Deborah Scott, Phone: 813-259-0965, Email: descott@health.usf.edu
Harry Van Loveren, MD, Principal Investigator

The University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Roberta (Bobbi) Reyes, Phone: 773-702-1800, Email: rreyes@surgery.bsd.uchicago.edu
Maciej Lesniak, MD, Principal Investigator

Evanston Northwestern University, Evanston, Illinois 60201, United States; Recruiting
Patricia Lada, Phone: 847-570-2025, Email: plada@enh.org
Nina Paleologos, MD, Principal Investigator

University of Iowa Hospitals and Clinics, Iowa City, Iowa 52242, United States; Recruiting
Melanie Frees, RN, Phone: 319-384-8288, Email: Melanie-Frees@uiowa.edu
Timothy Ryken, MD, Principal Investigator

Weill Medical College Department of Neurological Surgery, New York City, New York 10021, United States; Recruiting
Euphael Henry, MD, Phone: 212-746-2438, Email: euh2002@med.cornell.edu
Susan C Pannullo, MD, Principal Investigator

Carolina Neurosurgery & Spine Associates, Charlotte, North Carolina 28204, United States; Recruiting
Peggy Boltes, RN, Phone: 704-831-4006, Email: peggy.boltes@CNSA.com
Anthony Asher, MD, Principal Investigator

University of North Carolina, Chapel Hill, North Carolina 27599, United States; Recruiting
Layla Hilbun, Phone: 919-966-4432, Email: layla_hilbun@med.unc.edu
Matthew Ewend, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Kathy Robinson, Phone: 216-445-8624, Email: Robinsk2@ccf.org
Michael Vogelbaum, M.D., Ph.D., Principal Investigator

Temple University, Philadelphia, Pennsylvania 19140, United States; Recruiting
Emerson Clement, Phone: 215-707-4071, Email: emerson.clement@tuhs.temple.edu
Michael Weaver, MD, Principal Investigator

Methodist University Hospital, Memphis, Tennessee 38104, United States; Recruiting
Allen Redmond, Phone: 901-259-5314
Allen Sills, MD, Principal Investigator

Vanderbilt, Nashville, Tennessee 37232, United States; Recruiting
Cheri Stewart, Phone: 615-332-1880, Email: cheri.stewart@vanderbilt.edu
Kyle Weaver, MD, Principal Investigator

Trinity Mother Frances Neuroscience Institute, Tyler, Texas 75702, United States; Recruiting
Kevin Thornton, LVN, CCRC, Phone: 903-510-8862
Sabatino Bianco, MD, Principal Investigator

UT Southwestern Medical Center at Dallas, Dallas, Texas 75390, United States; Recruiting
Rosalie Serrano, RN, Phone: 214-648-7031, Email: rosalie.serrano@utsouthwestern.edu
Elizabeth Maher, MD, Principal Investigator

University of Washington Medical Center, Seattle, Washington 98195, United States; Recruiting
Sandra Kay Johnston, Phone: 206-288-6365
Marc Chamberlain, MD, Principal Investigator

Starting date: September 2007
Ending date: September 2009
Last updated: October 24, 2008