Trial record 1 of 1 for:    BTTC 11-01
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Lacosamide for Seizure Prophylaxis in High-Grade Gliomas

This study is currently recruiting participants.
Verified December 2013 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
BRAIN TUMOR TRIALS COLLABORATIVE (BTTC)
UCB, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01432171
First received: September 8, 2011
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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 Intervention
Brain Cancer
Drug: Lacosamide
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to First Seizure (TFS) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 302
Study Start Date: July 2012
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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. Patients must not have used any CYP2C19 inducers or inhibitors other than perioperative prophylactic anticonvulsants for at least 2 weeks prior to registration. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432171

Contacts
Contact: Mark R. Gilbert, MD,BS 713-792-2883

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
BRAIN TUMOR TRIALS COLLABORATIVE (BTTC)
UCB, Inc.
Investigators
Principal Investigator: Mark R. Gilbert, MD,BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01432171     History of Changes
Other Study ID Numbers: BTTC11-01
Study First Received: September 8, 2011
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014