Trials Sponsors Conditions Drugs Pricing

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

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Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)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Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)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Up to Month 12 (from baseline until evidence of neurological deterioration, had a local recurrence, withdrawn, died, lost to follow-up, or the study was closed)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

GLIADELDrug

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Eisai Inc.
Industrylead

Study Sites (17)

University of Arizona / University Medical Center

Tucson, Arizona, 85724, United States

University of California, Los Angeles

Los Angeles, California, 90095, United States

University of South Florida

Tampa, Florida, 33606, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

The University of Chicago

Chicago, Illinois, 60637, United States

NorthShore University HealthSystem Reseach Institute

Evanston, Illinois, 60201, United States

University of Iowa Hospitals and Clinics

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: 24037801DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Interventions

carmustine, poliferprosan 20 drug combination

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title: Eisai Medical Services
Organization: Eisai, Inc.

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

69 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (7)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (7)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations