Neoplasms

Nervous System Diseases

All Conditions

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Antineoplastic Agents

All Drugs and Chemicals

Carmustine

Antineoplastic Agents, Alkylating

Alkylating Agents

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.

GLIADEL

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.

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

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

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.

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).

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).

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.

Neurologic Death was defined as death due to progression of neurologic disease.

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.

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.

Eisai Inc.

The study team only has access to serious and all treatment-emergent adverse events (serious and non-serious). All efforts to locate other adverse event data have been exhausted. All treatment-emergent adverse events, whether serious or non-serious, have been reported in the Other (Not Including Serious) Adverse Events tables as severity of the event cannot be distinguished in available data.

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.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The safety analysis set included all enrolled participants who underwent surgical resection and received GLIADEL treatment.

Eisai Medical Services

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).

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.

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

Domains preserved=3

Domains preserved=2

Domains preserved=1

Domains preserved=0

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.

Number of Participants With Neurocognitive Domains Preserved at Month 2

Number of Participants With Neurocognitive Domains Preserved at Month 4

Number of Participants With Neurocognitive Domains Preserved at Month 6

Number of Participants With Neurocognitive Domains Preserved at Month 9

Number of Participants With Neurocognitive Domains Preserved at Month 12

Local Recurrence

Distant Recurrence

Overall Recurrence

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

Time to Local Recurrence

Time to Distant Recurrence

Time to Overall Recurrence

Time to Recurrence (Local, Distant and Overall)

PP1 population. Since only two participants had residual tumor mass, no correlation analyses were performed for recurrence and residual mass effect.

Correlation of Tumor Recurrence With Residual Mass Effect

Local Recurrence: MD at Visit (X-1)

Local Recurrence: MD Change at Visit (X-1)

Local Recurrence: MD Change at Visit (X+1)

Local Recurrence: MD Change at Visit (X+2)

Local Recurrence: MD Change at Visit (X+3)

Local Recurrence: EFD at Visit (X-1)

Local Recurrence: EFD Change at Visit (X-1)

Local Recurrence: EFD Change at Visit (X+1)

Local Recurrence: EFD Change at Visit (X+2)

Local Recurrence: EFD Change at Visit (X+3)

Local Recurrence: FMCD at Visit (X-1)

Local Recurrence: FMCD Change at Visit (X-1)

Local Recurrence: FMCD Change at Visit (X+1)

Local Recurrence: FMCD Change at Visit (X+2)

Local Recurrence: FMCD Change at Visit (X+3)

Distant Recurrence: MD at Visit (X-1)

Distant Recurrence: MD Change at Visit (X-1)

Distant Recurrence: MD Change at Visit (X+1)

Distant Recurrence: MD Change at Visit (X+2)

Distant Recurrence: MD Change at Visit (X+3)

Distant Recurrence: EFD at Visit (X-1)

Distant Recurrence: EFD Change at Visit (X-1)

Distant Recurrence: EFD Change at Visit (X+1)

Distant Recurrence: EFD Change at Visit (X+2)

Distant Recurrence: EFD Change at Visit (X+3)

Distant Recurrence: FMCD at Visit (X-1)

Distant Recurrence: FMCD Change at Visit (X-1)

Distant Recurrence: FMCD Change at Visit (X+1)

Distant Recurrence: FMCD Change at Visit (X+2)

Distant Recurrence: FMCD Change at Visit (X+3)

Overall Recurrence: MD at Visit (X-1)

Overall Recurrence: MD Change at Visit (X-1)

Overall Recurrence: MD Change at Visit (X+1)

Overall Recurrence: MD Change at Visit (X+2)

Overall Recurrence: MD Change at Visit (X+3)

Overall Recurrence: EFD at Visit (X-1)

Overall Recurrence: EFD Change at Visit (X-1)

Overall Recurrence: EFD Change at Visit (X+1)

Overall Recurrence: EFD Change at Visit (X+2)

Overall Recurrence: EFD Change at Visit (X+3)

Overall Recurrence: FMCD at Visit (X-1)

Overall Recurrence: FMCD Change at Visit (X-1)

Overall Recurrence: FMCD Change at Visit (X+1)

Overall Recurrence: FMCD Change at Visit (X+2)

Overall Recurrence: FMCD Change at Visit (X+3)

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

Percentage of Participants With Neurologic Death

Time to Neurocognitive Deterioration

Month 2: Memory Domain, decline <0 to -1 SD

Month 2: Memory Domain, decline <-1 to -2 SD

Month 2: Memory Domain, decline <-2 to -3 SD

Month 2: Memory Domain, decline <-3 to -4 SD

Month 2: Memory Domain, decline <-4 to -5 SD

Month 2: Memory Domain, decline <-5 SD

Month 2: EFD, decline <0 to -1 SD

Month 2: EFD, decline <-1 to -2 SD

Month 2: EFD, decline <-2 to -3 SD

Month 2: EFD, decline <-3 to -4 SD

Month 2: EFD, decline <-4 to -5 SD

Month 2: EFD, decline <-5 SD

Month 2: FMCD, decline <0 to -1 SD

Month 2: FMCD, decline <-1 to -2 SD

Month 2: FMCD, decline <-2 to -3 SD

Month 2: FMCD, decline <-3 to -4 SD

Month 2: FMCD, decline <-4 to -5 SD

Month 2: FMCD, decline <-5 SD

Month 4: Memory Domain, decline <0 to -1 SD

Month 4: Memory Domain, decline <-1 to -2 SD

Month 4: Memory Domain, decline <-2 to -3 SD

Month 4: Memory Domain, decline <-3 to -4 SD

Month 4: Memory Domain, decline <-4 to -5 SD

Month 4: Memory Domain, decline <-5 SD

Month 4: EFD, decline <0 to -1 SD

Month 4: EFD, decline <-1 to -2 SD

Month 4: EFD, decline <-2 to -3 SD

Month 4: EFD, decline <-3 to -4 SD

Month 4: EFD, decline <-4 to -5 SD

Month 4: EFD, decline <-5 SD

Month 4: FMCD, decline <0 to -1 SD

Month 4: FMCD, decline <-1 to -2 SD

Month 4: FMCD, decline <-2 to -3 SD

Month 4: FMCD, decline <-3 to -4 SD

Month 4: FMCD, decline <-4 to -5 SD

Month 4: FMCD, decline <-5 SD

Month 6: Memory Domain, decline <0 to -1 SD

Month 6: Memory Domain, decline <-1 to -2 SD

Month 6: Memory Domain, decline <-2 to -3 SD

Month 6: Memory Domain, decline <-3 to -4 SD

Month 6: Memory Domain, decline <-4 to -5 SD

Month 6: Memory Domain, decline <-5 SD

Month 6: EFD, decline <0 to -1 SD

Month 6: EFD, decline <-1 to -2 SD

Month 6: EFD, decline <-2 to -3 SD

Month 6: EFD, decline <-3 to -4 SD

Month 6: EFD, decline <-4 to -5 SD

Month 6: EFD, decline <-5 SD

Month 6: FMCD, decline <0 to -1 SD

Month 6: FMCD, decline <-1 to -2 SD

Month 6: FMCD, decline <-2 to -3 SD

Month 6: FMCD, decline <-3 to -4 SD

Month 6: FMCD, decline <-4 to -5 SD

Month 6: FMCD, decline <-5 SD

Month 9: Memory Domain, decline <0 to -1 SD

Month 9: Memory Domain, decline <-1 to -2 SD

Month 9: Memory Domain, decline <-2 to -3 SD

Month 9: Memory Domain, decline <-3 to -4 SD

Month 9: Memory Domain, decline <-4 to -5 SD

Month 9: Memory Domain, decline <-5 SD

Month 9: EFD, decline <0 to -1 SD

Month 9: EFD, decline <-1 to -2 SD

Month 9: EFD, decline <-2 to -3 SD

Month 9: EFD, decline <-3 to -4 SD

Month 9: EFD, decline <-4 to -5 SD

Month 9: EFD, decline <-5 SD

Month 9: FMCD, decline <0 to -1 SD

Month 9: FMCD, decline <-1 to -2 SD

Month 9: FMCD, decline <-2 to -3 SD

Month 9: FMCD, decline <-3 to -4 SD

Month 9: FMCD, decline <-4 to -5 SD

Month 9: FMCD, decline <-5 SD

Month 12: Memory Domain, decline <0 to -1 SD

Month 12: Memory Domain, decline <-1 to -2 SD

Month 12: Memory Domain, decline <-2 to -3 SD

Month 12: Memory Domain, decline <-3 to -4 SD

Month 12: Memory Domain, decline <-4 to -5 SD

Month 12: Memory Domain, decline <-5 SD

Month 12: EFD, decline <0 to -1 SD

Month 12: EFD, decline <-1 to -2 SD

Month 12: EFD, decline <-2 to -3 SD

Month 12: EFD, decline <-3 to -4 SD

Month 12: EFD, decline <-4 to -5 SD

Month 12: EFD, decline <-5 SD

Month 12: FMCD, decline <0 to -1 SD

Month 12: FMCD, decline <-1 to -2 SD

Month 12: FMCD, decline <-2 to -3 SD

Month 12: FMCD, decline <-3 to -4 SD

Month 12: FMCD, decline <-4 to -5 SD

Month 12: FMCD, decline <-5 SD

Percentage of Participants With Neurocognitive Decline in NF by Severity (Memory Domain, Executive Function Domain, and Fine Motor Coordination Domain)

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 \[milligram\] 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.

Overall Study

Spots Global Cancer Trial Database for Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafer in Patients With Metastatic Brain Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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