Brain and Central Nervous System TumorsNCT00415376
Levetiracetam in Treating Patients With Seizures Caused by Brain Metastases
A study testing levetiracetam and quality-of-life assessment in people with Brain and Central Nervous System Tumors and Seizure, run by Northwestern University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain and Central Nervous System Tumors, Seizure, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- levetiracetam and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
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.
Read the 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
- Being tested
- levetiracetam, quality-of-life assessment
- Keywords
- seizure, adult tumors metastatic to brain, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Central Nervous System Neoplasms, Seizures, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levetiracetamDrug
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure control (lack of seizure activity)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startFeb 2007
- Primary completionJul 2007
- Study completionJul 2007
Why it stopped: Unable to accrue subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey J. Raizer, MD, Principal investigator, Robert H. Lurie Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415376
- Sponsor's protocol ID
- CDR0000520380
- Other IDs
- NU-05CC11, NU-1398-032, UCB-NU-05CC11
- Status last verified
- May 2012
- First submitted
- 20 Dec 2006
- Last updated
- 18 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Efficacy of Levetiracetam in Patients With Seizures From Brain Metastases
- ClinicalTrials.gov ID
- NCT00415376
- Acronym / sponsor ID
- CDR0000520380
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to accrue subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007
- First posted
- 22 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levetiracetam | Drug | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Seizure control (lack of seizure activity)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey J. Raizer, MD principal investigator
Robert H. Lurie Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing levetiracetam and quality-of-life assessment in people with Brain and Central Nervous System Tumors and Seizure, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure control (lack of seizure activity). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2012.