W10TR-PRO1
- Conditions
- Castration resistant prostate cancer patients with or without previous chemotherapy
- Registration Number
- JPRN-jRCTs061180084
- Lead Sponsor
- Kitajima Kiyoaki
- Brief Summary
An immunotherapy using W10 peptide and Bordetella pertussis whole cell vaccine was tested against castration-resistant prostate cancer patients. No serious adverse events were observed. After 3 months of weekly immunotherapy 30% of the patients responded as CR, PR or NC. The immune-rel;ated tumor regulatory activity was observed in 45% of the patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 43
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.
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.
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