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Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases

This study has been withdrawn prior to enrollment.
(Unable to accrue subjects)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00415376
First received: December 20, 2006
Last updated: May 17, 2012
Last verified: May 2012
  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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00415376

Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeffrey J. Raizer, MD Robert H. Lurie Cancer Center
  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:
Central Nervous System Neoplasms
Neoplasms
Nervous System Neoplasms
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014