A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
18 Years
N/A
Both
Brain and Central Nervous System Tumors, Seizure, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
OBJECTIVES:
- Determine the optimal dose of levetiracetam required to control seizures from brain
metastases in patients with solid tumors.
- Determine the frequency of side effects and tolerability of this drug when used to
control seizures in these patients.
- Determine any improvement in antiepileptic drug-associated symptoms in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to baseline seizures (yes
vs no) and/or baseline antiepileptic drugs (AEDs) (yes vs no). Patients are assigned to 1 of
3 treatment groups.
- Group I (patients with no active baseline seizures): Patients receive oral
levetiracetam twice daily beginning on day 1.
- Group II (patients requiring IV AEDs for baseline seizure control): Patients receive
oral levetiracetam (instead of their current anticonvulsant therapy) twice daily
beginning on day 1, after their presenting condition has stabilized.
- Group III (patients with active seizures controlled by other concurrent anticonvulsant
monotherapy): Patients receive oral levetiracetam (instead of their current
anticonvulsant therapy) twice daily beginning on day 1. Treatment with the other
anticonvulsant drug is tapered beginning on day 3 as directed by the treating
physician.
In all groups, treatment continues for up to 6 months in the absence of uncontrolled
seizures or unacceptable toxicities.
During study therapy, patients maintain a seizure log that tracks frequency and type of
seizures. Any patient who experiences a breakthrough seizure or multiple auras receives
increasing doses of oral levetiracetam until the maximum dose is reached. Patients who
continue to have seizures at the maximum dose level receive a second antiseizure medication
at the discretion of the treating physician.
Quality of life is assessed by the Fundamental Assessment of Cancer Treatment-Brain
questionnaire at baseline and at 2 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor
- Pathological confirmation of brain metastasis is not required provided the
clinical and neuroradiographic picture is typical
- Has had at least one prior seizure due to brain metastasis
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 12 weeks
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 10 g/dL
- BUN < 5 times upper limit of normal (ULN)
- Creatinine < 5 times ULN
- Bilirubin < 1.5 times ULN
- AST and ALT ≤ 3 times ULN
- Alkaline phosphatase ≤ 2 times ULN
- No allergy to levetiracetam
PRIOR CONCURRENT THERAPY:
- Prior levetiracetam allowed provided it was initiated within the past 14 days
- Other concurrent anticonvulsant monotherapy allowed provided therapy was initiated
within the past 30 days
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Outcome Measure:
Seizure control (lack of seizure activity)
Principal Investigator
Jeffrey J. Raizer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000520380
NCT ID:
NCT00415376
Start Date:
February 2007
Completion Date:
July 2007
Related Keywords:
- Brain and Central Nervous System Tumors
- Seizure
- Unspecified Adult Solid Tumor, Protocol Specific
- seizure
- adult tumors metastatic to brain
- unspecified adult solid tumor, protocol specific
- Neoplasm Metastasis
- Nervous System Neoplasms
- Seizures
- Central Nervous System Neoplasms
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