W10TR-GBM2

JRCT ID: jRCTs061180085

Registered date:22/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Newly diagnosed malignant gliomas
• Date of first enrollment: 21/09/2010
• Target sample size: 90
• Study type: Interventional

Intervention(s)

1)WT1-W10 peptide immunotherapy
Intradermal injection of 3.0 mg/0.3ml of WT1-W10 peptide + 5x10^8/0.1ml of pertussis whole cell vaccine once a week.
2)Chemotherapy with temozolomide (TMZ)
An oral administration of 75 mg/m^2 of TMZ continues every day throughout the 6-week radiotherapy including weekends when irradiation is not performed (7 x 6 = 42 days). After the intermission of 4 weeks without radiotherapy or TMZ, chemotherapy is resumed for consecutive 5 days with a dose of 150 mg/m^2 every month. This monthly course of TMZ followed by 23-day intermission is repeated. The dose of TMZ may be increased up to 200 mg/m^2.

Outcome(s)

Primary Outcome

Evaluation of side effects (phase I)
Progression-free survival (phase II)

• Secondary Outcome: Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ueba Tetsuya
• Secondary Sponsor: Udaka Keiko
• Source(s) of Monetary Support: NEC Corporation
• Secondary ID(s): UMIN000002419