Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
Primary Purpose
Brain and Central Nervous System Tumors, Seizure, Unspecified Adult Solid Tumor, Protocol Specific
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
levetiracetam
quality-of-life assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring seizure, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Seizure control (lack of seizure activity)
Secondary Outcome Measures
Full Information
NCT ID
NCT00415376
First Posted
December 20, 2006
Last Updated
May 17, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00415376
Brief Title
Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
Official Title
A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to accrue subjects
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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 works in treating patients with seizures caused by brain metastases.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Seizure, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
seizure, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
levetiracetam
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Seizure control (lack of seizure activity)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J. Raizer, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
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