Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

NCT ID: NCT00415376

Last Updated: 2012-05-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-07-31

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.

Conditions

Brain and Central Nervous System Tumors; Seizure; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

levetiracetam

Intervention Type: DRUG

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey J. Raizer, MD

Role: PRINCIPAL_INVESTIGATOR

Robert H. Lurie Cancer Center

Other Identifiers

NU-05CC11

Identifier Type: -

Identifier Source: secondary_id

NU-1398-032

Identifier Type: -

Identifier Source: secondary_id

UCB-NU-05CC11

Identifier Type: -

Identifier Source: secondary_id

CDR0000520380

Identifier Type: -

Identifier Source: org_study_id