Unique ID issued by UMIN | UMIN000001821 |
---|---|
Receipt number | R000002198 |
Scientific Title | Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against recurrent prostate cancer: A phase I/II study |
Date of disclosure of the study information | 2009/03/31 |
Last modified on | 2009/09/08 10:32:45 |
Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against recurrent prostate cancer: A phase I/II study
An immunotherapy against recurrent prostate cancer
Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against recurrent prostate cancer: A phase I/II study
An immunotherapy against recurrent prostate cancer
Japan |
Prostate cancer
Urology |
Malignancy
NO
This study is undertaken to evaluate the safety and anti-tumor effects of an immunotherapy using WT1 peptide and pertussis whole cell vaccine against recurrent prostate cancer. Patients to be recruited must bear at least one copy of either HLA-A*0201, -A*0206 or –A*2402 gene and their tumors have resisted the conventional first line anti-tumor therapies.
Safety,Efficacy
Confirmatory
Pragmatic
Phase I,II
Evaluation of side effects (phase I)
Progression-free survival (phase II)
Disease control rate, survival rate, overall survival, Objective response rate, adverse events, immunological responses
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
3.0mg of WT1 peptide and 0.1ml of pertussis whole cell vaccine will be administrated intradermally. The administration interval is essentially every week.
20 | years-old | <= |
Not applicable |
Male
1) Treatment-failure prostate cancer patients who have been histologically diagnosed as prostate adenocarcinoma. Cases are divided into the following two categories.
a) Hormone-refractory prostate cancer patients who have not already received any chemotherapy yet.
b) Hormone-refractory prostate cancer patients who have already received one or more chemotherapies.
2) Patients must bear at lease one copy of either HLA-A*2402, -A*0201, or -A*0206 gene.
3) The tumor tissue is positibe by stained for WT1 by immunohistochemistry.
4) The patients' Karnofsky Index should be 60% or more(performance status(ECOG should be 0-2).
5) Expected survival time should be three months or greater.
6) Sufficient function of important organs including heart, lung, liver, kidney and bome marrow. And patients must satisfy the followings:
Creatinin <= 3.0mg/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 >= 8.0g/dl
ECG: no serious object
SpO2 >= 94% (room air)
7) Patients without additional malignant diseases
8) Written informed consents are obtained from patients after giving sufficient explanations and obtaining their understandings about disease conditions.
The following patients must be excluded:
1) Patients with uncontrollable infectious disease (including active Tuberculosis).
2) Patients with severe symptoms (malignant hypertension, severe congestive heart failure, severe colonary insufficiency, Myocardial Infarction within three months lately, terminal phase liver cirrhosis, uncontrollable Diabetes Mellitus, severe Pulmonary Fibrosis, active interstitial pneumonia, etc.).
3) Patients previously treated with Allogeneic bone marrow transplantation.
4) Patients with severe psychiatric disease.
5) Patients who participate in any other clinical trial.
6) Patients who previously participated in this clinical trial.
7) Any patients disqualified by a study physician because of medical, psychological, or any other factors.
60
1st name | |
Middle name | |
Last name | Kiyoaki Kitajima |
Kitajima Hospital
Department of Urology
1662 Ochi-koh, Ochi-cho, Takaoka-gun, Kochi
1st name | |
Middle name | |
Last name |
Kitajima Hospital
Department of Urolog
wakaayu@lime.ocn.ne.jp
Department of Immunology, Kochi University School of Medicine
Japan Science and Technology Agency
Other
NO
2009 | Year | 03 | Month | 31 | Day |
Unpublished
Open public recruiting
2009 | Year | 03 | Month | 27 | Day |
2009 | Year | 03 | Month | 01 | Day |
2015 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 31 | Day |
2009 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002198