None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : 1. Dosage: 1 bag 100mL for each administration (more than 2.0x10?cells of activated mixed lymphocyte derived from autologous blood).
2. Administration cycle and n
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who voluntarily decided to participate and gave written consent after hearing about the characteristics of this clinical trial and clinical trial drugs 2) Adults between the ages of 19 and 70 3) As a glioblastoma patient, ? Diagnosed as glioblastoma confined to the supratentorial compartment in imaging diagnosis, ? Glioblastoma (IDH-wild type) confirmed at the time of surgery or by histological examination afterward 4) Those who scored 2 points or less on ECOG 5) Those who are scheduled to undergo radiation and temozolomide combination therapy (CCRT) after tumor removal surgery
Exclusion criteria
Exclusion criteria: 1) Recurrent glioblastoma 2) Leptomeningeal dissemination and other distant metastasis (bone marrow, lung, liver, etc.) glioblastoma 3) When only tumor tissue biopsy was performed 4) Applicants of Gliadel wafer or local brachytherapy 5) Those who cannot perform MRI according to the clinical trial schedule 6) If toxicity of previous treatment has not recovered to baseline level or CTCAE Grade 1 or lower, except for alopecia 7) Past or current medical history of newly diagnosed cardiovascular disease within 3 months prior to participation in this clinical trial that is not controlled by the following (1) congestive heart failure (2) myocardial infarction (3) Unstable angina with new drug administration or dose change within 3 months (4) Arrhythmias with pacemaker implantation (5) Transient ischemic attack (TIA) or stroke with neurologic deficits 8) Severe renal impairment (CrCl 38.5°C (101.3°F) judged unlikely to participate in the clinical trial. 17) Previous history of hypersensitivity to the ingredients constituting this clinical trial drug (CLZ-3002 active ingredient and excipient) 18) The following contraindications to Temozolomide. (1) Previous history of hypersensitivity to temozolomide or dacarbazine (2) galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 19) Diclofenac acid Contraindications 20) Subjects who received contraindicated medicines or treatments before participating in clinical trials and for whom the specified period has not elapsed 21) Patients scheduled to receive concomitantly contraindicat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS);OS Hazard ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) rate;PFS Hazard ratio;12-month and 24-month OS rate;Post-progression survival;ECOG score;Neurologic Assessment in Neuro-Oncology (NANO) scale;European Organization for Research and Treatment Care Quality of Life Questionnaire;Association between baseline characteristics (6-MGMT methylation & extent-of-resection) and survivals (PFS & OS);Association between immune markers [Cytokine (TNF-a etc.) & serum immune cells (T, NK cells etc.)] and survivals (PFS & OS);Adverse events;Physical examination and vital signs;Lab results for hematology, serum chemistry, urinalysis and coagulation | — |
Countries
Korea, Republic of
Contacts
Public ContactHwang Kihwan
Seoul National University Bundang Hospital
Outcome results
None listed