Metastatic Brain CancerPhase 2NCT00525590

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

A Phase 2 study testing GLIADEL in people with Metastatic Brain Cancer, run by Eisai Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Brain Cancer
What is being tested?: GLIADEL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 17 sitesUnited States
Study dates: 12 Dec 2007to 1 Dec 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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);
OR
an intra-operative diagnosis of metastatic brain tumor in a patient with a single brain lesion.

Show all 11Show fewer

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

University of North Carolina
Chapel Hill, North Carolina, 27599
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204
The University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
NorthShore University HealthSystem Reseach Institute
Evanston, Illinois, 60201
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of California, Los Angeles
Los Angeles, California, 90095
Methodist University Hospital
Memphis, Tennessee, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Medical College Department of Neurological Surgery
New York, New York, 10021
Temple University
Philadelphia, Pennsylvania, 19140
University of South Florida
Tampa, Florida, 33606
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
University of Arizona / University Medical Center
Tucson, Arizona, 85724
Trinity Mother Frances Health System
Tyler, Texas, 75702

Other trials in United States

About this study

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

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
Being tested: GLIADEL
Keywords: Gliadel
Medical subject headings: Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT00525590
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: GLIADEL

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Month 12

Secondary outcomes (7)

Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence)
Measured: 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)
Measured: 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
Measured: 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
The correlation between recurrence (local, distant or overall) \& NF was assessed by presenting change in NF domain scores (memory domain [MD], executive function domain [EFD], fine motor coordination domain [FMCD]) after tumor recurrence (Visits X, X+1, X+2, and X+3) compared to before tumor recurrence (Visit X-1). Here 'Visit X' refers to visit at which participants had tumor recurrence, Visit X-1 refers to visit immediately before the recurrence and X+1, X+2, X+3 refers to subsequent first, second \& third visit after the recurrence.NF domain z-scores were derived from participant's scores in individual neurocognitive tests using an age-adjusted \&education-adjusted normative distribution of scores from an unimpaired population. Individual z-scores from related tests were averaged to determine overall z-score for each of NF domains.
Measured: 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
Neurologic Death was defined as death due to progression of neurologic disease.
Measured: 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 Neurocognitive Deterioration
The time to neurocognitive deterioration was defined as the number of days between the date of study treatment and the date of neurocognitive deterioration based on NF assessment. This was assessed using Kaplan Meier method.
Measured: 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 Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain)
Neurocognitive decline was defined as any decrease in NF scores less than (<) 0 SD from baseline. Here, in category titles EFD represents Executive Function Domain and FMCD represents Fine Motor Coordination Domain.
Measured: Months 2, 4, 6, 9 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 20071 Dec 2010

First posted6 Sep 2007 (estimated)
Study start12 Dec 2007
Primary completion1 Dec 2010
Study completion1 Dec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metastatic Brain CancerStudies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00525590
Sponsor's protocol ID: GLIA-001
Status last verified: Feb 2020
First submitted: 4 Sep 2007
Last updated: 16 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 24037801

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer
ClinicalTrials.gov ID: NCT00525590
Acronym / sponsor ID: GLIA-001
Conditions: Metastatic Brain Cancer
Keywords: Gliadel
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: 12 Dec 2007 (actual)
Primary completion: 1 Dec 2010 (actual)
Study completion: 1 Dec 2010 (actual)
First posted: 6 Sep 2007 (estimated)
Results: Posted 16 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: GLIADEL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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);
OR

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GLIADELResect 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.	Drug	1

Primary outcome

Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12
Time frame: 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.
Number of Participants With Neurocognitive Domains Preserved at Month 2
Time frame: 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).
Number of Participants With Neurocognitive Domains Preserved at Month 4
Time frame: 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).
Number of Participants With Neurocognitive Domains Preserved at Month 6
Time frame: 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).
Number of Participants With Neurocognitive Domains Preserved at Month 9
Time frame: 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).
Number of Participants With Neurocognitive Domains Preserved at Month 12
Time frame: 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).

7 secondary outcomes

Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Neurocognitive Deterioration
Time frame: 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 Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain)
Time frame: Months 2, 4, 6, 9 and 12

Results and safety

Results posted to the registry on 16 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GLIADEL	59	14

Primary outcome: Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12

Time frame: Month 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	GLIADEL n = 54
Value	2.8 (0.40 to 18.13)

Population analysed: The per protocol 1 (PP1) population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example whole brain radiation therapy \[WBRT\]) before recurrence.

Primary outcome: Number of Participants With Neurocognitive Domains Preserved at Month 2

Time frame: Month 2. Count of participants. Unit: Participants

Measure	GLIADEL n = 54
Domains preserved=3	26
Domains preserved=2	12
Domains preserved=1	4
Domains preserved=0	3

Population analysed: The PP1 population included all participants who received surgery plus GLIADEL, had an intra-operative diagnosis confirmed by permanent pathology findings, remained compliant with protocol procedures, and did not receive disallowed concomitant therapies (example WBRT) before recurrence.

Primary outcome: Number of Participants With Neurocognitive Domains Preserved at Month 4

Time frame: Month 4. Count of participants. Unit: Participants

Measure	GLIADEL n = 54
Domains preserved=3	24
Domains preserved=2	9
Domains preserved=1	2
Domains preserved=0	1

Primary outcome: Number of Participants With Neurocognitive Domains Preserved at Month 6

Time frame: Month 6. Count of participants. Unit: Participants

Measure	GLIADEL n = 54
Domains preserved=3	17
Domains preserved=2	5
Domains preserved=1	2
Domains preserved=0	0

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening up to 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GLIADEL	40 of 59 (67.8%)	53 of 59 (89.8%)	9 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24037801Brem 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLIADEL in people with Metastatic Brain Cancer, run by Eisai Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12 (time frame: Month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00525590, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.