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

NCT ID: NCT00525590

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-12
• Study Completion Date: 2010-12-01

Brief 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.

Conditions

Metastatic Brain Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

GLIADEL

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Arizona / University Medical Center

Tucson, Arizona, United States

University of California, Los Angeles

Los Angeles, California, United States

University of South Florida

Tampa, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

The University of Chicago

Chicago, Illinois, United States

NorthShore University HealthSystem Reseach Institute

Evanston, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Weill Medical College Department of Neurological Surgery

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Temple University

Philadelphia, Pennsylvania, United States

Methodist University Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Trinity Mother Frances Health System

Tyler, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24037801 (View on PubMed)

Other Identifiers

GLIA-001

Identifier Type: -

Identifier Source: org_study_id