Lacosamide in Preventing Seizures in Participants With Malignant Glioma

NCT01432171 | Terminated Results FDA Drug

• 3 other identifiers: BTTC11-01NCI-2018-01854P30CA016672
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well lacosamide works in preventing seizures in participants with malignant glioma. Anti-seizure drugs, such as lacosamide, may decrease abnormal electrical activity in the brain that plays a role in developing seizures.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Seizures

  Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)

  12 months or first seizure

Study Arms (2)

Arm I (lacosamide)

EXPERIMENTAL

Participants receive lacosamide PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: Lacosamide

Arm II (placebo)

PLACEBO COMPARATOR

Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Other: Placebo

Interventions

Lacosamide DRUG

Given PO

Also known as: ADD 234037, Erlosamide, Harkoseride, SPM 927, Vimpat

Arm I (lacosamide)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed supratentorial high-grade glioma will be eligible for this protocol.
• All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
• Patients must have signed an authorization for the release of their protected health information.
• Patients must have a Karnofsky performance status of \>= 60.
• Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 2 weeks prior to registration.
• In the opinion of the treating investigator, patients must have adequate cognitive abilities to complete the neurocognitive components of the study.
• Patients must be able to safely swallow pills.
• Patients must agree to practice adequate contraception.
• Patients must be registered on study within 16 weeks after the surgical procedure that established the diagnosis of high grade glioma.

You may not qualify if:

• 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.
• 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. f) Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (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.
• 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.
• Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
• Patients must not have a history of heart block or cardiac arrhythmia, including asymptomatic arrhythmias and atrial fibrillation/flutter.
• Patients must not have a prolonged PR interval (defined as \> 200 ms).
• Perioperative anticonvulsants should be tapered as indicated in the protocol.
• Patients must not have a history of any type of seizure for at least 10 years prior to registration.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Glioma

Interventions

Lacosamide; 2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Limitations and Caveats

This is a cooperative group protocol. It was not an MDACC protocol. BTTC was administratively located at MDACC. The main PI/Academic PI was located at an outside institution.

Results Point of Contact

• Title: Dr. Andrew Norden, M.D., M.P.H. - Lead Principal Investigator
• Organization: Dana-Farber Cancer Institute

anorden@partners.org

617-632-2166

Study Officials

• Marta Penas-Prado

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 12, 2011
• Study Start: July 25, 2012
• Primary Completion: June 20, 2017
• Study Completion: June 20, 2017
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-11

Locations

US (1)