Metastatic Brain Cancer
Conditions
Keywords
Gliadel
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.
Interventions
DRUGGLIADEL
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.
Sponsors
Eisai Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12 | 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 | 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 | 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 | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Months 2, 4, 6, 9 and 12 | 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. |
| 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) | 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. |
| 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) | Neurologic Death was defined as death due to progression of neurologic disease. |
| Time to Neurocognitive Deterioration | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 12 sites in the United States from 12 December 2007 to 01 December 2010.
Pre-assignment details
A total of 82 participants with metastatic brain cancer were screened, of which 69 participants were enrolled and 59 participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| GLIADEL Participants with metastatic brain tumors who underwent neurosurgical resection of their lesions were implanted with up to 8 GLIADEL wafers in their tumor cavities (each containing 7.7 mg of carmustine). Participants were followed up to 12 months or until the participant experienced local recurrence, withdrew, died, was lost to follow-up, or the study was closed. | 59 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 13 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | GLIADEL |
|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 55 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 59 |
| other Total, other adverse events | 53 / 59 |
| serious Total, serious adverse events | 40 / 59 |
Outcome results
Primary
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).
Time frame: Month 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 12 | Domains preserved=3 | 9 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 12 | Domains preserved=2 | 5 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 12 | Domains preserved=1 | 0 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 12 | Domains preserved=0 | 0 Participants |
Primary
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).
Time frame: Month 2
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 2 | Domains preserved=3 | 26 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 2 | Domains preserved=2 | 12 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 2 | Domains preserved=1 | 4 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 2 | Domains preserved=0 | 3 Participants |
Primary
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).
Time frame: Month 4
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 4 | Domains preserved=3 | 24 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 4 | Domains preserved=2 | 9 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 4 | Domains preserved=1 | 2 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 4 | Domains preserved=0 | 1 Participants |
Primary
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).
Time frame: Month 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 6 | Domains preserved=1 | 2 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 6 | Domains preserved=3 | 17 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 6 | Domains preserved=2 | 5 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 6 | Domains preserved=0 | 0 Participants |
Primary
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).
Time frame: Month 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 9 | Domains preserved=3 | 14 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 9 | Domains preserved=2 | 6 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 9 | Domains preserved=1 | 0 Participants |
| GLIADEL | Number of Participants With Neurocognitive Domains Preserved at Month 9 | Domains preserved=0 | 0 Participants |
Primary
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.
Time frame: Month 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLIADEL | Rate of Deterioration in Neurocognitive Functioning (NF) at Month 12 | 2.8 percentage of participants |
Secondary
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.
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)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: MD at Visit (X-1) | -0.9 z-score | Standard Deviation 1.21 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: MD Change at Visit (X-1) | -1.1 z-score | Standard Deviation 1.11 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: MD Change at Visit (X+1) | 0.7 z-score | Standard Deviation 0.38 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: MD Change at Visit (X+2) | 0.1 z-score | Standard Deviation 1.8 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: MD Change at Visit (X+3) | -0.8 z-score | — |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: EFD at Visit (X-1) | -0.4 z-score | Standard Deviation 1.76 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: EFD Change at Visit (X-1) | -0.5 z-score | Standard Deviation 0.62 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: EFD Change at Visit (X+1) | 0.2 z-score | Standard Deviation 0.89 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: EFD Change at Visit (X+2) | -0.0 z-score | Standard Deviation 0.74 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: EFD Change at Visit (X+3) | -1.1 z-score | — |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: FMCD at Visit (X-1) | -1.5 z-score | Standard Deviation 1.65 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: FMCD Change at Visit (X-1) | 0.4 z-score | Standard Deviation 0.59 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: FMCD Change at Visit (X+1) | 0.5 z-score | Standard Deviation 0.53 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: FMCD Change at Visit (X+2) | -0.4 z-score | Standard Deviation 0.7 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Local Recurrence: FMCD Change at Visit (X+3) | 0.3 z-score | — |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: MD at Visit (X-1) | -1.0 z-score | Standard Deviation 1.04 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: MD Change at Visit (X-1) | 0.2 z-score | Standard Deviation 1.35 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: MD Change at Visit (X+1) | -0.2 z-score | Standard Deviation 1.02 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: MD Change at Visit (X+2) | -0.2 z-score | Standard Deviation 1.77 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: MD Change at Visit (X+3) | -0.7 z-score | Standard Deviation 0.07 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: EFD at Visit (X-1) | -0.2 z-score | Standard Deviation 1.44 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: EFD Change at Visit (X-1) | -0.2 z-score | Standard Deviation 0.82 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: EFD Change at Visit (X+1) | -0.5 z-score | Standard Deviation 1.11 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: EFD Change at Visit (X+2) | -0.8 z-score | Standard Deviation 1.2 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: EFD Change at Visit (X+3) | -0.8 z-score | Standard Deviation 0.39 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: FMCD at Visit (X-1) | -1.2 z-score | Standard Deviation 1.32 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: FMCD Change at Visit (X-1) | -0.1 z-score | Standard Deviation 0.61 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: EFD Change at Visit (X+1) | -0.5 z-score | Standard Deviation 1.01 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: FMCD Change at Visit (X+1) | -0.4 z-score | Standard Deviation 0.99 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: FMCD Change at Visit (X+2) | -1.1 z-score | Standard Deviation 1.03 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Distant Recurrence: FMCD Change at Visit (X+3) | -0.1 z-score | Standard Deviation 0.48 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: MD at Visit (X-1) | -0.9 z-score | Standard Deviation 1.15 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: MD Change at Visit (X-1) | -0.1 z-score | Standard Deviation 1.4 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: MD Change at Visit (X+1) | -0.1 z-score | Standard Deviation 0.96 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: MD Change at Visit (X+2) | -0.2 z-score | Standard Deviation 1.67 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: MD Change at Visit (X+3) | -0.7 z-score | Standard Deviation 0.07 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: EFD at Visit (X-1) | -0.1 z-score | Standard Deviation 1.47 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: EFD Change at Visit (X-1) | -0.3 z-score | Standard Deviation 0.76 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: EFD Change at Visit (X+2) | -0.6 z-score | Standard Deviation 0.98 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: EFD Change at Visit (X+3) | -0.8 z-score | Standard Deviation 0.39 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: FMCD at Visit (X-1) | -1.2 z-score | Standard Deviation 1.31 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: FMCD Change at Visit (X-1) | 0.0 z-score | Standard Deviation 0.69 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: FMCD Change at Visit (X+1) | -0.3 z-score | Standard Deviation 0.92 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: FMCD Change at Visit (X+2) | -0.9 z-score | Standard Deviation 0.95 |
| GLIADEL | Correlation of Tumor Recurrence (Local, Distant or Overall) With NF Domain Scores | Overall Recurrence: FMCD Change at Visit (X+3) | -0.1 z-score | Standard Deviation 0.48 |
Secondary
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)
Population: PP1 population. Since only two participants had residual tumor mass, no correlation analyses were performed for recurrence and residual mass effect.
Secondary
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)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GLIADEL | Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence) | Local Recurrence | 28.0 percentage of participants |
| GLIADEL | Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence) | Distant Recurrence | 48.0 percentage of participants |
| GLIADEL | Percentage of Participants With Brain Tumor Recurrence (Local Recurrence, Distant Recurrence and Overall Recurrence) | Overall Recurrence | 62.0 percentage of participants |
Secondary
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.
Time frame: Months 2, 4, 6, 9 and 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: EFD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: Memory Domain, decline <0 to -1 SD | 27.3 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: Memory Domain, decline <-1 to -2 SD | 15.9 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: Memory Domain, decline <-2 to -3 SD | 4.5 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: Memory Domain, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: Memory Domain, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: Memory Domain, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: EFD, decline <0 to -1 SD | 37.8 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: EFD, decline <-1 to -2 SD | 8.1 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: EFD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: EFD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: EFD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: FMCD, decline <0 to -1 SD | 23.8 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: FMCD, decline <-1 to -2 SD | 7.1 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: FMCD, decline <-2 to -3 SD | 2.4 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: FMCD, decline <-3 to -4 SD | 2.4 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: FMCD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 2: FMCD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: Memory Domain, decline <0 to -1 SD | 19.4 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: Memory Domain, decline <-1 to -2 SD | 8.3 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: Memory Domain, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: Memory Domain, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: Memory Domain, decline <-4 to -5 SD | 2.8 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: Memory Domain, decline <-5 SD | 2.8 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: EFD, decline <0 to -1 SD | 29.0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: EFD, decline <-1 to -2 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: EFD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: EFD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: EFD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: EFD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: FMCD, decline <0 to -1 SD | 17.1 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: FMCD, decline <-1 to -2 SD | 11.4 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: FMCD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: FMCD, decline <-3 to -4 SD | 2.9 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: FMCD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 4: FMCD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: Memory Domain, decline <0 to -1 SD | 12.5 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: Memory Domain, decline <-1 to -2 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: Memory Domain, decline <-2 to -3 SD | 4.2 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: Memory Domain, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: Memory Domain, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: Memory Domain, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: EFD, decline <0 to -1 SD | 18.2 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: EFD, decline <-1 to -2 SD | 4.5 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: EFD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: EFD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: EFD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: EFD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: FMCD, decline <0 to -1 SD | 12.5 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: FMCD, decline <-1 to -2 SD | 20.8 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: FMCD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: FMCD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: FMCD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 6: FMCD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: Memory Domain, decline <0 to -1 SD | 25.0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: Memory Domain, decline <-1 to -2 SD | 5.0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: Memory Domain, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: Memory Domain, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: Memory Domain, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: Memory Domain, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: EFD, decline <0 to -1 SD | 36.8 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: EFD, decline <-1 to -2 SD | 5.3 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: EFD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: EFD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: EFD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: EFD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: FMCD, decline <0 to -1 SD | 20.0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: FMCD, decline <-1 to -2 SD | 10.0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: FMCD, decline <-2 to -3 SD | 5.0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: FMCD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: FMCD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 9: FMCD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: Memory Domain, decline <0 to -1 SD | 14.3 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: Memory Domain, decline <-1 to -2 SD | 7.1 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: Memory Domain, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: Memory Domain, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: Memory Domain, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: Memory Domain, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: EFD, decline <0 to -1 SD | 33.3 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: EFD, decline <-1 to -2 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: EFD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: EFD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: EFD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: EFD, decline <-5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: FMCD, decline <0 to -1 SD | 7.1 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: FMCD, decline <-1 to -2 SD | 14.3 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: FMCD, decline <-2 to -3 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: FMCD, decline <-3 to -4 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: FMCD, decline <-4 to -5 SD | 0 percentage of participants |
| GLIADEL | Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain) | Month 12: FMCD, decline <-5 SD | 0 percentage of participants |
Secondary
Percentage of Participants With Neurologic Death
Neurologic Death was defined as death due to progression of neurologic disease.
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)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLIADEL | Percentage of Participants With Neurologic Death | 1.9 percentage of participants |
Secondary
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.
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)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLIADEL | Time to Neurocognitive Deterioration | NA months |
Secondary
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)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GLIADEL | Time to Recurrence (Local, Distant and Overall) | Time to Local Recurrence | NA months |
| GLIADEL | Time to Recurrence (Local, Distant and Overall) | Time to Distant Recurrence | 8.5 months |
| GLIADEL | Time to Recurrence (Local, Distant and Overall) | Time to Overall Recurrence | 6.1 months |