UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010388
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

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Basic information

Public title

Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer

Acronym

Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer

Scientific Title

Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer

Scientific Title:Acronym

Clinical trial of WT1 and MUC1 peptide-pulsed dendritic cell vaccine for post-operative patients with pancreatic cancer or biliary cancer

Region

Japan


Condition

Condition

pancreatic cancer, biliary cancer

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Adverse events

Key secondary outcomes

relapse free survival
antitumor immune response


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

Administer WT1 and MUC1 peptide-pulsed dendritic cell vaccination every 2weeks for a total of 7 times.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

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

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiro Nagai

Organization

Nagasaki University Hospital

Division name

Transfusion and Cell Therapy Unit

Zip code


Address

Sakamoto 1-7-1, Nagasaki, Japan

TEL

095-819-7493

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Nagai

Organization

Nagasaki University Hospital

Division name

Transfusion and Cell Therapy Unit

Zip code


Address

Sakamoto 1-7-1, Nagasaki, Japan

TEL

095-819-7493

Homepage URL


Email



Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tella, Inc.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

長崎大学病院


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 01 Day


Related information

URL releasing protocol

http://ar.iiarjournals.org/cgi/pmidlookup?view=long&pmid=32988904

Publication of results

Published


Result

URL related to results and publications

http://ar.iiarjournals.org/cgi/pmidlookup?view=long&pmid=32988904

Number of participants that the trial has enrolled

10

Results

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.

Results date posted

2021 Year 02 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

Candidates for this study were consecutively enrolled during the registration period.

Adverse events

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.

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 01 Month 28 Day

Date of IRB

2013 Year 02 Month 20 Day

Anticipated trial start date

2013 Year 03 Month 01 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 01 Day

Last modified on

2021 Year 02 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012154


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name