Adult-type diffuse glioma, CNS WHO grade 2-3 glioma, astrocytoma, oligodendroglioma
Conditions
Interventions
Administration of Fycompa (tablet, dry syrup, or intravenous formulation
Eisai Co., Ltd.) will be carried out in patients diagnosed with adult-type diffuse glioma, CNS WHO grade 2-3 by stereotactic biopsy, who require craniotomy for tumor resection and have symptomatic epi
C551441
Perampanel
Sponsors
Ozono Iori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The provisional diagnosis by robot-assisted stereotactic tumor biopsy is adult-type diffuse glioma, CNS WHO grade 2-3. 2. The patient requires craniotomy for tumor resection. 3. The patient has symptomatic epilepsy. 4. The patient has no history of perampanel administration. 5. The performance status (ECOG) is 0-2. 6. The patient is not currently undergoing chemotherapy, molecular targeted therapy, or radiotherapy for another malignancy. 7. Written informed consent to participate in the study has been obtained from the patient. 8. The patient is 18 years of age or older.
Exclusion criteria
Exclusion criteria: 1. The patient has a tumor located in an area that is considered unresectable. 2. The patient presents with severe hepatic dysfunction. 3. The patient has evidence of metastatic or disseminated disease. 4. The patient has an active infection requiring systemic treatment. 5. The patient has a fever of 38.0 degrees C or higher at the time of enrollment. 6. The patient is either untested or positive for HIV antibodies, or has a primary immunodeficiency syndrome such as X-linked agammaglobulinemia, chronic granulomatous disease, or Wiskott-Aldrich syndrome, or has an iatrogenic immunodeficiency due to organ transplantation or a condition requiring treatment with steroids or methotrexate. 7. The patient has psychiatric disorders or psychiatric symptoms that, in the judgment of the investigator, make participation in the study difficult. 8. The patient is pregnant or breastfeeding. 9. The patient has drug allergies that prevent the use of both gadolinium-based and iodine-based contrast agents. 10. The patient is deemed unsuitable for study participation by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of cases in which the Ki-67 index decreased by 20% or more in the pathological specimen obtained at the second surgery compared to that of the initial surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of decrease in Ki-67 index (difference in Ki-67 index between pathological specimens from the initial surgery and the second surgery). 2. Increase rate of apoptosis (difference in apoptosis measured by Terminal deoxynucleotidyl transferase dUTP Nick-End Labeling [TUNEL] assay between pathological specimens from the initial surgery and the second surgery). 3. AMPA receptor activity (difference in expression levels of AMPA receptor subunits between pathological specimens from the initial surgery and the second surgery). 4. Difference in tumor volume during the treatment period. 5. Proportion of patients who were able to continue taking perampanel for at least 4 weeks. 6. Differences in the reduction rate of Ki-67 index and the increase rate of apoptosis among oligodendroglioma, astrocytoma, and glioma NOS other than oligodendroglioma or astrocytoma. | — |
Contacts
Public ContactFumiyuki Yamasaki
Hiroshima University Hospital
Outcome results
None listed