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Trial record 1 of 14 for:    Recruiting Studies | Interventional Studies | glioma | United States | Start date from 10/09/2020 to 01/05/2021
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Effect of Perampanel on Peritumoral Hyperexcitability in HGG

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ClinicalTrials.gov Identifier: NCT04497142
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : August 13, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eisai Inc.
Information provided by (Responsible Party):
Jong Woo Lee, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date August 13, 2021
Actual Study Start Date  ICMJE November 5, 2020
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
Rate of high frequency oscillations [ Time Frame: Peri-operative ]
The effect of perampanel on peritumoral hyperexcitability will be measured using intraoperative electrocorticography (ECoG) at the time of initial glioma resection to analyze high frequency oscillations (80-500 Hz). The rate of high frequency oscillations over 10 minutes of recording in the tumor margins will be compared between participants receiving perampanel versus standard of care treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
Seizure-free rates [ Time Frame: Up to 12 months ]
The clinical effect of perampanel maintenance therapy on seizure control will be measured by seizure-free rates between the time of initial glioma resection and radiographic tumor progression (up to a maximum of 12 months), and compared to seizure-free rates in participants receiving standard of care treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Perampanel on Peritumoral Hyperexcitability in HGG
Official Title  ICMJE Pilot Study of Perampanel on Peritumoral Hyperexcitability and Seizure Control in Newly Diagnosed High Grade Glioma
Brief Summary

The purpose of this research study is to learn more about seizures in people with primary brain tumors. It will evaluate whether an antiseizure medication decreases hyperexcitability activity around tumors and prevents seizures.

The procedure and study drug involved in this study are:

  • Electrocorticography
  • Perampanel (Fycompa)
Detailed Description

This research study is a Pilot Study, which is the first time investigators are examining brain activity after taking perampanel.

The U.S. Food and Drug Administration (FDA) has approved perampanel as a treatment option for seizures. It has not been approved for the treatment of brain tumors. Recording of brain activity (electrocorticography) during surgery is an established clinical procedure, which will be performed for investigational purposes. This research study is studying brain recordings and perampanel treatment in participants with brain tumors for the following reasons:

  • People with brain tumors commonly have seizures.
  • Perampanel was developed as an anti-seizure medication, which works by blocking a signaling pathway between brain cells, mediated by AMPA receptors.
  • Previous research has shown abnormal brain activity around tumors resulting from increased AMPA receptor activation.
  • Perampanel is expected to decrease abnormal brain activity and prevent seizures by blocking AMPA receptor signaling.

This study involves two groups of participants, one group who receives the antiseizure medication perampanel, and the other group who receives the usual antiseizure medication (typically levetiracetam) at the time of surgery. Participants have the option to choose which group to participate if they have a preference.

The research study procedures include screening for eligibility, recording brain activity during surgery, and study treatment including evaluations and follow up visits. Participants will receive the study drug for as long as they do not have serious side effects and their disease does not get worse, up to a maximum of 12 months.

It is expected that about 20 people will take part in this research study.

The National Institute of Health (NIH) is supporting this study by providing funding for the research. Eisai Inc, a pharmaceutical company, is supporting this research study by providing the study medication.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioma, Malignant
  • Surgery
  • Seizures
Intervention  ICMJE
  • Drug: Perampanel
    Tablet taken orally 1x daily.
    Other Names:
    • E2007
    • Fycompa
  • Drug: Standard of Care
    Predetermined standard of care drug and dosing
    Other Name: Standard treatment (typically the anti-seizure medication levetiracetam)
Study Arms  ICMJE
  • Experimental: Perampanel
    • Participants will take a predetermined first dose of perampanel on the day before their tumor surgery
    • During surgery, an approximately 4x6cm recording grid will be placed on the surface of the brain over the tumor, and brain activity around the tumor will be recorded for 10 minutes during surgery (Electrocorticography).
    • After surgery participants will take perampanel at a predetermined dose once a day for as long as they do not have serious side effects and their disease does not get worse, up to a maximum of 12 months. Participants will be provided a drug and seizure diary to document drug and seizure information and have monthly study visits either in clinic or by phone.
    Intervention: Drug: Perampanel
  • Active Comparator: Standard of Care
    • Participants will receive standard of care medication before surgery.
    • During surgery, an approximately 4x6cm recording grid will be placed on the surface of the brain over the tumor, and brain activity around the tumor will be recorded for 10 minutes during surgery (Electrocorticography).
    • After surgery participants will take standard of care medications as predetermined by their doctor. Participants will be provided a drug and seizure diary to document drug and seizure information and have monthly study visits either in clinic or by phone.
    • Participants will be followed up to 12 months after completing surgery.
    Intervention: Drug: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2023
Estimated Primary Completion Date March 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have radiologic evidence of anaplastic astrocytoma or glioblastoma multiforme within 14 days of enrollment.
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with CT or MRI. See Section 11 (Measurement of Effect) for the evaluation of measurable disease.
  • Age ≥18 years.
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
  • Participants must have adequate organ and marrow function as defined below:

    • absolute neutrophil count ≥1,500/mcL
    • platelets ≥100,000/mcL
    • total bilirubin ≤ institutional upper limit of normal (ULN)
    • AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
    • glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2 (see Appendix B)
  • Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
  • The effects of perampanel on the developing human fetus are unknown. For this reason and because some anti-seizure medications are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants with brain metastases due to confounding effects on the study objectives.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to perampanel.
  • Participants receiving any medications or substances that are moderate or strong inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
  • Participants with uncontrolled intercurrent illness.
  • Participants with psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because perampanel is an anti-seizure agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with perampanel, breastfeeding should be discontinued if the mother is treated with perampanel.
  • Participants with a history of suicide attempt or current active suicidal ideation with intent as defined by Columbia Suicide Severity Rating Scale (C-SSRS) type 4-5, due to the potential for suicidal ideation with the use of all anti-seizure medications.
  • Participants who are unable to swallow pills.
  • Participants with tumor associated seizures greater than one month before planned surgery.
  • Participants currently receiving treatment with more than one anti-seizure medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jong Woo Lee, MD, PhD (617) 732-7432 jlee38@bwh.harvard.edu
Contact: Steven Tobochnik, MD (617) 732-7432 stobochnik@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04497142
Other Study ID Numbers  ICMJE 20-059
2P50CA165962-06A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Steven Tobochnik, MD at stobochnik@bwh.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
Responsible Party Jong Woo Lee, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Eisai Inc.
Investigators  ICMJE
Principal Investigator: Jong Woo Lee, MD, PhD Brigham and Women's Hospital
PRS Account Dana-Farber Cancer Institute
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP