Clinical trial NCT00415376: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Seizure control (lack of seizure activity)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Jeffrey J. Raizer, MD
role: PRINCIPAL_INVESTIGATOR
References: