Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed Over 18 NCI, Pharmaceutical / Industry NU-05CC11 NU-1398-032, UCB-NU-05CC11, NCT00415376

Objectives

1. Determine the optimal dose of levetiracetam required to control seizures from brain metastases in patients with solid tumors.
2. Determine the frequency of side effects and tolerability of this drug when used to control seizures in these patients.
3. Determine any improvement in antiepileptic drug-associated symptoms in these patients.

Entry 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

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

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

Expected Enrollment

A total of 30 patients will be accrued for this study.

Outcomes

Seizure control (lack of seizure activity)

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Jeffrey Raizer, MD, Principal investigator		Ph: 312-503-4724 Email: jraizer@NMFF.org

Registry Information
Official Title		A Pilot Study of the Efficacy of Levetiracetam in Patients with Seizures from Brain Metastases
Trial Start Date		2007-02-12
Trial Completion Date		2007-10-31
Registered in ClinicalTrials.gov		NCT00415376
Date Submitted to PDQ		2006-11-03
Information Last Verified		2007-02-12
NCI Grant/Contract Number		CA60553