Clinical trial NCT00525590: Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Brain Cancer
Keywords: Gliadel
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-06
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12
timeFrame: Month 12
measure: Number of Participants With Neurocognitive Domains Preserved at Month 2
timeFrame: Month 2
measure: Number of Participants With Neurocognitive Domains Preserved at Month 4
timeFrame: Month 4
measure: Number of Participants With Neurocognitive Domains Preserved at Month 6
timeFrame: Month 6
measure: Number of Participants With Neurocognitive Domains Preserved at Month 9
timeFrame: Month 9
measure: Number of Participants With Neurocognitive Domains Preserved at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence)
timeFrame: 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)
measure: Time to Recurrence (Local, Distant and Overall)
timeFrame: 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)
measure: Correlation of Tumor Recurrence With Residual Mass Effect
timeFrame: 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)
measure: Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores
timeFrame: 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)
measure: Percentage of Participants With Neurologic Death
timeFrame: 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)
measure: Time to Neurocognitive Deterioration
timeFrame: 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)
measure: Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain)
timeFrame: Months 2, 4, 6, 9 and 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona / University Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem Reseach Institute
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: New York
country: United States
facility: Weill Medical College Department of Neurological Surgery
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Health System
state: Texas
Study officials:
References:
citation: 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.