Status:
WITHDRAWN
Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Seizure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Anticonvulsant drugs, such as levetiracetam, may help control seizures caused by brain metastases. PURPOSE: This clinical trial is studying the side effects and how well levetiracetam work...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00415376
Start Date
February 1 2007
End Date
July 1 2007
Last Update
May 18 2012
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