WT1 peptide immunotherapy in combination with surgery, irradiation, and temozolomide chemotherapy for malignant glioma: A phase I/II study. - W10TR-GBM2

eba Tetsuya0 个研究点目标入组 90 人开始时间: 2019年3月22日最近更新: 2023年10月17日

试验速览

暂无简介。

•Malignant glioma patients who are going to receive radiation therapy and temozolomide chemotherapy. Surgery before/after this trial is optional.
•1)Patients who have not received tumor-specific pretreatment.
•2)Patients must have at least one copy of either HLA-A*24:02, -A*02:01, or -A*02:06 gene.
•3)The tumor tissue is positive for WT1 expression by immunohistochemical staining.
•4)Karnofsky Index should be 60% or higher (performance status by ECOG should be 0-2).
•5)Expected survival time should be three months or longer.
•6)Sufficient functions are maintained in critical organs including heart, lung, liver, kidney, and bone marrow. Patients must satisfy all of the followings:
•Creatinin <= 3.0 mg/dl
•BUN <= 25 mg/dl
•Total Bilirubin <= 1.5 mg/dl
•AST <= 105 U/l
•ALT <=120 U/l
•Neutrophil >= 1,600/mm^3
•Platelet >= 100,000/mm^3
•Hemoglobin >= 8.0 g/dl
•ECG: no serious object
•Sp02 >= 94% (in room air)
•7)Patients without acompanying malignant diseases.
•8)Written informed consents are obtained from patients after providing sufficient information on disease condition and the treatment.

•1)Patients with uncontrollable infectious diseases, including active tuberculosis.
•2)Patients with serious complications (malignant hypertension, severe congestive heart failure, severe coronary insufficiency, myocardial infarction within three months, terminal stage liver cirrhosis, poorly controlled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia, etc.).
•3)Patients who have received allogeneic bone marrow transplant.
•4)Patients who are pregnant or in breast-feeding.
•5)Patients with severe psychiatric disorders.
•6)Patients who participate in other clinical trials.
•7)Patients who previously participated in this clinical trial.
•8)Any patients disqualified by a study physician because of medical, psycological, or any other reasons.

发起方

eba Tetsuya