Unique ID issued by UMIN | UMIN000010388 |
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Receipt number | R000012154 |
Scientific Title | Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer |
Date of disclosure of the study information | 2013/04/01 |
Last modified on | 2021/02/15 13:55:51 |
Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer
Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer
Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer
Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer
Japan |
pancreatic cancer, biliary cancer
Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Malignancy
NO
To assess the safety and efficacy of WT1 and MUC1 peptide-pulsed dendritic cell vaccination for post-operative patients with pancreatic cancer or biliary cancer
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
Adverse events
relapse free survival
antitumor immune response
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine |
Administer WT1 and MUC1 peptide-pulsed dendritic cell vaccination every 2weeks for a total of 7 times.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
1) Reveal of expression of WT1 for tumor cell from resected specimen
2) Administering of gemcitabine or S-1 as an adjuvant treatment after curative resection (treatment for preoperative is not considered)
3) HLA(HLA-A2402, HLA-A0201,
HLA-A0206) of compatible types for WT1 peptide
4) Age between 20 to 80 years old
5) Performance status(ECOG) 0,1
6) Not be receiving any other clinical trial or investigational
7) Require initial protocol treatment within 12 weeks postoperatively
8) Tolerable cardiovascular system for apheresis to harvest peripheral-blood mononuclear
9) The ability to fully understand and sign a written informed consent for the clinical trial
10) Requiredment of following initial laboratory values within 14 days prior to registration
WBC >=3,000/mm3
Absolute neutrophil count 1,500/mm3
Hemoglobin >=9.0g/dL
Platelet >=100,000/mm3
Total bilirubin <1.5mg/dL
AST <=100IU/mL
ALT <=100IU/mL
Creatinine <1.2mg/dL
Creatinine clearance>=60mL/min
11) Negative reaction for hepatitis B virus antigen, hepatitis C virus, HTLV-1 and HIV
1) Active primary malignancies
2) History of OK-432 and penicillin G allergy
3) Complication of uncontrolled hypertensionpiesia and diabetes
4) Unstable angina pectoris (within 3weeks) or cardiac infarct in past 6 months
5) Significant cardiac disease such as uncontrolled congestive heart failure or arrhythmia
6) Complication of pulmonary fibrosis, interstitial peumonia interstitial lung disease or double lung disease in the past or present. The same as the suspected disease from imaging findings
7) Bleeding peptic ulceration, intestinal paralysis or ileus
8) Taking immunosuppressive or corticosteroid (predonine or prednisolone 10mg for a day)
9) Pregnant and lactating women. Ineligible birth controlled men and women
10) Judged that have merged the mental disease or the neurological manifestation and the participation in this trial is difficult
11) Infant(under 20 years of age)
12) Inadequate for this study through doctor's judgment
10
1st name | |
Middle name | |
Last name | Kazuhiro Nagai |
Nagasaki University Hospital
Transfusion and Cell Therapy Unit
Sakamoto 1-7-1, Nagasaki, Japan
095-819-7493
1st name | |
Middle name | |
Last name | Kazuhiro Nagai |
Nagasaki University Hospital
Transfusion and Cell Therapy Unit
Sakamoto 1-7-1, Nagasaki, Japan
095-819-7493
Nagasaki University Hospital
None
Self funding
Tella, Inc.
NO
長崎大学病院
2013 | Year | 04 | Month | 01 | Day |
http://ar.iiarjournals.org/cgi/pmidlookup?view=long&pmid=32988904
Published
http://ar.iiarjournals.org/cgi/pmidlookup?view=long&pmid=32988904
10
Ten patients were enrolled and no Grade 2 or higher toxicities were associated with DC vaccination. The estimated overall survival (OS) and relapse-free survival (RFS) at 3-years from the time of surgical resection were 77.8% and 35.0%, respectively. Immunohistochemical analysis suggested a possible relationship between induction of WT1-specific cytotoxic T lymphocyte after DC vaccination and higher infiltration of CD3/CD4/CD8 lymphocytes in tumor tissues.
2021 | Year | 02 | Month | 15 | Day |
Eligible patients met the following criteria: 18 to 80 years of age, were diagnosed with PDA, underwent respective operations after initial diagnosis, had Eastern Cooperative Oncology Group performance status (PS) of 0-1, had normal organ function, had no chemotherapy-disqualifying sign of infectious disease, had no blood abnormality or bleeding tendency, had no apheresis-disqualifying history of cardiovascular disease or respiratory disorders, and had human leukocyte antigen (HLA) class I genotypes compatible with restriction of the WT1 peptide.
Candidates for this study were consecutively enrolled during the registration period.
The most common AE of any grade was skin reaction (erythema) at the DC vaccine injection site (n=9, 90.0%). Meanwhile, fever (n=6, 60.0%) was observed in six patients, including three patients (30.0%) with Grade 1 fever . Both AEs recurred in most cases and disappeared after a few days. Grade 1 fatigue was observed in six patients (60.0%). Grade 1 leukocytopenia, neutropenia, and anemia were observed in 3, 3, and 1 of the 10 patients, respectively. Other non-hematologic AEs included grade 1 anorexia, diarrhea, hepatic transaminase, and gamma-glutamyl transpeptidase elevation, all of which have been previously reported as major AEs associated with S-1 or GEM. Overall, no Grade 2 or higher CTCAE v5.0 toxicities were found to be associated with DC vaccination. Therefore, no patient discontinued DC vaccination. Although four patients died during the observation period, relapse and progression of PDA was the cause of death in all four patients as described below.
WT1/MUC1-DC vaccination in the adjuvant setting was safe and well-tolerated in PDA patients after tumor resection. A large-scale prospective study is warranted to evaluate the clinical benefit of this modality.
Completed
2013 | Year | 01 | Month | 28 | Day |
2013 | Year | 02 | Month | 20 | Day |
2013 | Year | 03 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2013 | Year | 04 | Month | 01 | Day |
2021 | Year | 02 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012154
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