None listed
Conditions
Interventions
Drug : Registered subjects will initiate bevacizumab plus erlotinib between 2 and 3 weeks after gamma knife surgery. Bevacizumab will be administered at 10 mg/kg every 2 weeks, and erlotinib will be a
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals who voluntarily provided written consent to participate in this study 2. ECOG performance status 0-2 3. Males and females aged 19 years or older and 80 years or younger 4. Patients with disease progression confirmed after standard chemotherapy (procarbazine plus lomustine plus vincristine or temozolomide or irinotecan plus bevacizumab) or radiation therapy 5. Patients with lesions amenable to Gamma Knife Surgery (GKS) 6. Glioma patients with next-generation sequencing-detected IDH1/2 mutations (R132 for IDH1, R140 or R172 for IDH2) 7. Patients with at least one measurable lesion 8. Patients with adequate organ function A. Absolute neutrophil count (ANC) =1500 cells/mm³ B. Platelets =100,000 cells/mm³ C. Total bilirubin =1.5 x upper limit of normal (ULN) D. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5.0 x ULN E. Serum creatinine =1.5 x ULN or CCr = 50mL/min (calculated using the weight-based Cockcroft-Gault formula) 9. Female subjects must either be non-childbearing age or agree to use an appropriate contraceptive method during the clinical trial period. ? Female patients must agree to use an appropriate contraceptive method and must not be breastfeeding. For women of childbearing potential, evidence of non-childbearing status must be provided prior to dosing, either through a negative pregnancy test or by meeting one of the following criteria during screening: - “Postmenopausal” women over 50 years of age who have discontinued all exogenous hormone therapy and have been amenorrheic for at least 12 months. - A history of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (tubal ligation is not acceptable). - Women aged 50 or younger are considered postmenopausal only if they have been amenorrheic for at least 12 months after discontinuing all exogenous hormone therapy, and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels fall within the postmenopausal range established by the trial site. - All participants must use reliable contraception during all sexual intercourse with any partner from the screening period until 24 weeks after discontinuing the trial therapy. - From the screening period until 24 weeks after discontinuation of the clinical trial treatment, reliable contraception must be used during all sexual intercourse with any partner. ? For male patients who have not undergone vasectomy, all of the following must be agreed to: - From the screening period until 24 weeks after discontinuation of the clinical trial treatment, reliable contraception must be used during all sexual intercourse with any partner. - From the start of the clinical trial treatment until 24 weeks after discontinuation, sperm donation is not permitted. - Must not donate sperm from the day the trial therapy begins until 24 weeks after discontinuation of the trial therapy. - If a male patient wishes to have children during the aforementioned period, must be advised to arrange for the freezing of sperm samples before starting the trial therapy. 10. Individuals who understand the trial content, are cooperative with trial procedures, and are deemed capable of participating until the study's completion. 11. Patients capable of oral intake, or patients deemed by the investigator to be capable of receiving oral medication via L-tube feeding or feeding gastrostomy.
Exclusion criteria
Exclusion criteria: 1. Individuals deemed unsuitable by other investigators 2. Patients unable to receive oral nutrition or nutrition via L-tube feeding or feeding gastrostomy 3. Uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, or active infection. 4. Patients with interstitial lung disease or drug-induced interstitial lung disease requiring steroid therapy. 5. Toxicity not resolved from prior therapy, > Grade 1 per CTCAE. 6. Pregnant or lactating women. 7. Exclusion of patients with prior or concurrent malignancy (however, registration is possible if cured with no recurrence within 5 years) 8. Serious conditions including the following -Clinically significant and uncontrolled arrhythmia -History of myocardial infarction within 6 months prior to initiation of the investigational drug -Psychiatric disorders or dementia that would interfere with compliance with the requirements of this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Confirmed objective response rate (ORR) by RANO-BM | — |
Countries
Korea, Republic of
Contacts
Public ContactSe-Hoon Lee
Samsung Medical Center
Outcome results
None listed