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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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


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)
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