Unique ID issued by UMIN | UMIN000004855 |
---|---|
Receipt number | R000005779 |
Scientific Title | Phase I pilot study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with gemcitabine for patients with advanced pancreatic cancer |
Date of disclosure of the study information | 2011/01/15 |
Last modified on | 2015/05/09 19:41:53 |
Phase I pilot study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with gemcitabine for patients with advanced pancreatic cancer
Phase I pilot study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with gemcitabine for patients with advanced pancreatic cancer (DC5)
Phase I pilot study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with gemcitabine for patients with advanced pancreatic cancer
Phase I pilot study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with gemcitabine for patients with advanced pancreatic cancer (DC5)
Japan |
unresectable pancreatic cancer
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To assess the safety of the WT1 peptide pulsed dendritic cell vaccination combined with gemcitabine for patients with unresectable advanced pancreatic cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase I
Adverse events
Response rate
Progression free survival
Overall survival
Immune induction (Delayed type hypersensensitivity DTH for WT1 peptide)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Vaccine |
Gemcitabine 1,000 mg/m2/day day1,8,15
Dendritic cell day8,15
q4w , 3 cycle
20 | years-old | <= |
75 | years-old | >= |
Male and Female
1)Histological diagnosis of pancreatic cancer
2)Cancer cells express WT1
3)Possess HLA-A2402
4)Patients don't have immediate allergy to WT1 peptide
5)Obtains lesion that can be evaluated by RECIST
6)Four weeks or more must pass from the prior treatment
7)performance status (ECOG) 0, 1
8)Adequate hematologic, hepatic, renal, and cardiac function
a)WBC >=3,000/mm3
b)Absolute neutrophil count 1,500/mm3
c)Platelet >=100,000/mm3
d)Hemoglobin >=9.0g/dL
e)AST and ALT <=150IU/L
f)Total bilirubin <3.0mg/dL
g)Creatinine <1.5mg/dL
h)ECG normal
9)Patients expected of four months or more survival
10)Written informed consent
1)Active other primary malignancies
2)Past history of severe allergy
3)Severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes)
4)Pleural effusion or pericardial fluid requiring treatment
5)Pregnancy, nursing women
6)Male hope to impregnate
7)Carrier of HBV, HTLV-1, HIV and so on
8)Severe psychiatric disease
9)Symptomatic interstitial pneumonia or fibroid lung that be diagnosed by X-ray
10)Past history of autoimmune disease
11)During treatment with immunosuppressive agents
12)Patients whom doctors judged inadequate to the enrollment of this study by other reasons
10
1st name | |
Middle name | |
Last name | Yuko Kitagawa |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+813-3353-1211ext.62334
kitagawa@a3.keio.jp
1st name | |
Middle name | |
Last name | Minoru Kitago |
School of Medicine, Keio University
Department of Surgery
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+813-3353-1211ext.62334
dragonpegasus@a3.keio.jp
School of Medicine, Keio University
None
Self funding
Tokyo Midtown Medical Center
tella,Inc.
NO
2011 | Year | 01 | Month | 15 | Day |
Published
Completed
2010 | Year | 10 | Month | 13 | Day |
2011 | Year | 01 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2011 | Year | 01 | Month | 10 | Day |
2015 | Year | 05 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005779
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |