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

NCT00525590 | Completed Phase 2 Results DMC

• 1 other identifier: GLIA-001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 17

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

Keywords

Gliadel

Outcome Measures

Primary Outcomes (6)

• Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12

  NF was assessed as the performance of 3 neurocognitive domains:memory(MD),executive function(EFD), fine motor coordination(FMCD). For each domain, z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted and education-adjusted normative distribution of scores from an unimpaired population.Individual z-scores from related tests were averaged to determine overall z-score.If a z-score average decreased from baseline by greater than or equal to(\>=)3 standard deviations(SD)in tests' normative age-adjusted distribution on 2 consecutive visits or decreased by \>=3 SD on last follow-up visit, participant were considered to have significant deterioration in their NF at time of the first decrease in z-score.Deterioration in NF:demonstrated deterioration for at least two of the three neurocognitive domains based on these changes from screening.Rate of deterioration in NF was measured as estimated percentage of participants using Kaplan-Meier method.

  Month 12

• Number of Participants With Neurocognitive Domains Preserved at Month 2

  Preservation of NF was defined as a decrease of \<=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).

  Month 2

• Number of Participants With Neurocognitive Domains Preserved at Month 4

  Preservation of NF was defined as a decrease of \<=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).

  Month 4

• Number of Participants With Neurocognitive Domains Preserved at Month 6

  Preservation of NF was defined as a decrease of \<=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).

  Month 6

• Number of Participants With Neurocognitive Domains Preserved at Month 9

  Preservation of NF was defined as a decrease of \<=1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).

  Month 9

• Number of Participants With Neurocognitive Domains Preserved at Month 12

  Preservation of NF was defined as a decrease of less than or equal to (\<=) 1 SD, any increase, or no change (0 SD) in z-score for each domain (memory domain, executive function domain, and fine motor coordination domain).

  Month 12

Secondary Outcomes (7)

• Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence)

  Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)

• Time to Recurrence (Local, Distant and Overall)

  Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)

• Correlation of Tumor Recurrence With Residual Mass Effect

  Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)

• Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores

  Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)

• Percentage of Participants With Neurologic Death

  Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)

Study Arms (1)

1

EXPERIMENTAL

Drug: GLIADEL

Interventions

GLIADEL 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Can provide signed/dated Informed Consent, and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.
• Are a male or female patient 18 years of age or older.
• 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.
• 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);
• an intra-operative diagnosis of metastatic brain tumor in a patient with a single brain lesion.
• Have a life expectancy of ≥12 weeks.
• Have a Karnofsky Performance Status (KPS) score of 70 or higher.
• Have Recursive Partitioning Analysis (RPA) status of 1 or 2.
• Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of the surgical resection; and
• Patients must be able to understand English, either orally or in writing, and be able to consent and complete the required assessments and procedures.

You may not qualify if:

• Are unable or unwilling to understand study assessment or to cooperate with the study procedures as determined by the investigator.
• Have a history of allergic reaction or known hypersensitivity to BCNU (carmustine) or other components of the GLIADEL, such as polifeprosan polymer.
• Have a history of prior cranial irradiation.
• Have a prior diagnosis of Central Nervous System (CNS) tumor.
• Have received prior treatment for brain tumors.
• Have had prior exposure to GLIADEL or its components, such as polifeprosan polymer.
• Have any uncontrolled medical or psychiatric conditions which preclude them from participating in or completing the study procedures.
• 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.
• Have a diagnosis of tumor in the brain stem or posterior fossa.
• Have an RPA status of 3.
• Have a diagnosis of leptomeningeal disease at time of enrollment; or
• Are currently pregnant or lactating, or plan to become pregnant during the course of the study.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (17)

University of Arizona / University Medical Center

Tucson, Arizona, 85724, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

NorthShore University HealthSystem Reseach Institute

Evanston, Illinois, 60201, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Weill Medical College Department of Neurological Surgery

New York, New York, 10021, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Methodist University Hospital

Memphis, Tennessee, 38104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Trinity Mother Frances Health System

Tyler, Texas, 75702, United States

Location

Related Publications (1)

• 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.

  PMID: 24037801 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

carmustine, poliferprosan 20 drug combination

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai, Inc.

esi_medinfo@eisai.com

1-888-422-4743

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 6, 2007
• Study Start: December 12, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-02

Locations

US (17)