Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00415376
• Other study ID #: CDR0000520380
• Secondary ID: NU-05CC11NU-1398
• Status: Withdrawn
• Phase: N/A
• First received: December 20, 2006
• Last updated: May 17, 2012
• Start date: February 2007
• Est. completion date: July 2007

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms
• Seizure
• Seizures
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• levetiracetam

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure control (lack of seizure activity)