Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors Seizure Unspecified Adult Solid Tumor, Protocol Specific |
Drug: levetiracetam Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Supportive Care |
| Official Title: | A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases |
- Seizure control (lack of seizure activity)
| Enrollment: | 0 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | July 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00415376 History of Changes |
| Other Study ID Numbers: | CDR0000520380, NU-05CC11, NU-1398-032, UCB-NU-05CC11 |
| Study First Received: | December 20, 2006 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
seizure adult tumors metastatic to brain unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Nervous System Neoplasms Seizures Central Nervous System Neoplasms Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site Nervous System Diseases Epilepsy Brain Diseases Central Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Etiracetam Piracetam Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Nootropic Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013