Phase IV, Prospective, Randomized, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication using a Glutaminergic Modulator in Patients with Drug-Resistant Focal Epilepsy and High-Grade Glioma

Overview

About this study

The purpose of this study is to evaluate the effectiveness of Perampanel on seizure frequency in adult patients with brain-tumor with and without seizures associated with glioma.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Histological confirmation of melanoma. Patients may have completed biopsy outside of
Mayo Clinic, but there must be an internal review done to confirm diagnosis prior to
confirming eligibility

- Measurable or non-measurable disease

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 3

- sPD-L1 levels > 1.7 ng/ml by enzyme-linked immunosorbent assay (ELISA)

- Feasible vascular access as determined by study apheresis technician (either by
peripheral intravenous access or by placement of a temporary central line)

- Negative pregnancy test done =< 7 days prior to radiation therapy, for women of
childbearing potential only

- Provide written informed consent

- Willing to return to enrolling institution for follow-up (during the Active Monitoring
Phase of the study)

- Willing to provide blood samples for correlative research purposes

Exclusion Criteria:

- Persons taking a biotin supplement

- sPD-L1 level < 1.7 ng/ml by ELISA

- Pregnant or nursing women

- Men or women of childbearing potential who are unwilling to employ adequate
contraception

Eligibility last updated 6/8/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

William Tatum, D.O.

Open for enrollment

Contact information:

Amber Baskin CCRP

(904)953-9675

Baskin.Amber@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions