W10TR-GBM2

Phase 1

Recruiting

• Conditions: ewly diagnosed malignant gliomas

• Registration Number: JPRN-jRCTs061180085
• Lead Sponsor: eba Tetsuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of side effects (phase I)<br>Progression-free survival (phase II)

Secondary Outcome Measures

Name	Time	Method
Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses.