W10TR-PRO1

JRCT ID: jRCTs061180084

Registered date:22/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Castration resistant prostate cancer patients with or without previous chemotherapy
• Date of first enrollment: 26/03/2009
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 3.0 mg of WT1 peptide and 5x10^8 inactivated pertussis whole cell vaccine in 0.1 ml will be administered intradermally. The treatment interval is essentially every week.

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: 20age
• Age maximum: Not applicable
• Gender: Male

Include criteria

General criteria
Disease-specific inclusion criteria
1) Patients who were diagnosed as prostate cancer by pathological examination and received the standard therapy including operation, radiotherapy and hormone
therapy, but had experienced recurrence by the criteria using serum PSA level. Patients were divided into the following two groups.
a. patients without previous chemotherapy
b. patients resistant to chemotherapy by the PSA criteria
2) 20 years of age or older. The upper limit is not set for the elderly, but physical status must be evaluated carefully whether he is well enough to complete the trial.
3) Patients must have at least one copy of either HLA-A*24:02, -A*02:01, -A*02:06, or -A*02:07 gene.
4) Positive for WT1 expression in the tumor tissue.
5) Karnofsky Index is 60% or higher (by ECOG performance status: 0-2).
6) Life expectancy is 3 months or longer.
7) Function of critical organs (heart, lung, liver, kidney and bone marrow) is maintained. The following data must be satisfied:
Creatinin =< 3.0 mg/dl
BUN =< 25 mg/dl
Total Bilirubin =< 1.5 mg/dl
AST =< 105 U/l
ALT =< 120 U/l
Neutrophil => 1,500/mm3
Platelet => 75,000/mm3
Hemoglobin => 8.0 g/dl
ECG:no serious problems
SpO2 => 94% (in room air)
8) No serious diseases or double malignancies.
9) Written informed consents are obtained from patients.

Exclude criteria

The following patients are excluded:
1)Patients with uncontrollable infectious diseases including active tuberculosis.
2)No serious complications (malignant hypertension, severe congestive heart failure, severe coronary insufficiency, myocardial infarction within three months, terminal phase liver cirrhosis, uncontrollable diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia, etc.).
3)After allogeneic bone marrow transplantation.
4)Patients with severe psychiatric diseases.
5)Patients who are enrolled in other clinical trials.
6)Patients who have previously participated in this clinical trial.
7)Any patients disqualified by study physicians due to clinical or other reasons.

Related Information

• Primary Sponsor: Kitajima Kiyoaki
• Secondary Sponsor: Udaka Keiko
• Source(s) of Monetary Support: NEC Corporation
• Secondary ID(s): UMIN000001821