Lacosamide for Seizure Prophylaxis in High-Grade Gliomas

Study Description

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Brief Summary:

The goal of this clinical research study is to learn if an antiepileptic (anti-seizure) treatment will prevent seizures in patients with brain tumors who have not yet had a seizure. Anti-seizure drugs are designed to decrease abnormal electrical activity in the brain that plays a role in developing seizures.

In this study, lacosamide will be used as an anti-seizure medication. Lacosamide will be compared to a placebo.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Condition or disease	Intervention/treatment	Phase
Brain Cancer	Drug: Lacosamide; Other: Placebo	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	302 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas
Study Start Date :	July 2012
Estimated Primary Completion Date :	July 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Lacosamide; Lacosamide or placebo will be taken by mouth twice a day, at approximately the same time each day, spaced as close to 12 hours apart as possible. The starting dose of lacosamide or placebo will be 50 mg PO bid. Over 4 weeks, the dose should be increased to a target dose of 200 mg bid. A recommended scheme for dose escalation is to increase by 100 mg/day weekly until 200 mg bid is achieved.	Drug: Lacosamide; Starting dose: 50 mg by mouth twice a day.; Other Name: Vimpat
Placebo Comparator: Placebo; Lacosamide or placebo will be taken by mouth twice a day, at approximately the same time each day, spaced as close to 12 hours apart as possible. The starting dose of lacosamide or placebo will be 50 mg PO bid. Over 4 weeks, the dose should be increased to a target dose of 200 mg bid. A recommended scheme for dose escalation is to increase by 100 mg/day weekly until 200 mg bid is achieved.	Other: Placebo; To be taken by mouth twice daily.; Other Name: sugar pill

Outcome Measures

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Primary Outcome Measures :

1. Time to First Seizure (TFS) [ Time Frame: 1 month ]
   The primary measure of efficacy is time to first seizure (TFS). The primary test of the difference in TFS between the treatment arms based on the likelihood ratio statistic for the treatment effect in a stratified proportional hazards regression model with anticonvulsant use as the stratification factor. The conditional power for the time-to-event outcome computed based on the method described in Design and Analysis of Clinical Trials with Time-to-Event Endpoints and Lan Simon and Halperin.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patients with histologically confirmed supratentorial high-grade glioma will be eligible for this protocol.
2. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
3. Patients must have signed an authorization for the release of their protected health information.
4. Patients must be >/= 18 years old.
5. Patients must have a Karnofsky performance status of >/= 60.
6. Women of childbearing potential must have a negative beta-HCG pregnancy test documented within 2 weeks prior to registration.
7. In the opinion of the treating investigator, patients must have adequate cognitive abilities to complete the neurocognitive components of the study.
8. Patients must be able to safely swallow pills.
9. Patients must agree to practice adequate contraception.
10. Patients must be registered on study within 16 weeks after the surgical procedure that established the diagnosis of High Grade Glioma.

Exclusion Criteria:

1. Patients must not have any significant medical or psychiatric illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
2. Patients must not have serious intercurrent medical illness. Serious, active co-morbidity, defined as follows: a) Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months. b) Transmural myocardial infarction within the last 6 months. c) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. d) Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. e) Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
3. (2. continued) f) Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. g) Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
4. Patients must not be pregnant or breast feeding. Patients must not be pregnant because lacosamide produced developmental toxicity in rats following administration during pregnancy. There is insufficient information to determine if lacosamide is safe during lactation.
5. Patients must not have any disease that will obscure toxicity or dangerously alter Drug metabolism
6. Patients must not have a history of heart block or cardiac arrhythmia, including asymptomatic arrhythmias and atrial fibrillation/flutter.
7. Patients must not have a prolonged PR interval (defined as > 200 ms).
8. Perioperative anticonvulsants should be tapered as indicated in the protocol.
9. Patients must not have a history of any type of seizure for at least 10 years prior to registration.

Contacts and Locations

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Locations

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
Rush University Medical Center
Chicago, Illinois, United States, 60612
Northshore University Health System
Evanston, Illinois, United States, 60201
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202-2608
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53234

Sponsors and Collaborators

M.D. Anderson Cancer Center

Brain Tumor Trials Collaborative

UCB Pharma

Investigators

Principal Investigator:	Marta Penas-Prado, MD	M.D. Anderson Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01432171 History of Changes
Other Study ID Numbers:	BTTC11-01; NCI-2011-03055 ( Registry Identifier: NCI CTRP )
First Posted:	September 12, 2011
Last Update Posted:	May 26, 2016
Last Verified:	May 2016

Keywords provided by M.D. Anderson Cancer Center:

Brain cancer; Central nervous system; Seizure prophylaxis; High-Grade Gliomas; HGG; Supratentorial high-grade glioma	Malignant glioma; Lacosamide; Vimpat; Placebo; Sugar pill

Additional relevant MeSH terms:

Glioma; Seizures; Brain Neoplasms; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Epilepsy	Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Lacosamide; Anticonvulsants