UMIN-CTR Clinical Trial

Public title

Pilot study of WT1 peptide vaccine therapy for chemorefractory advanced pancreatic cancer

Acronym

Wt1 peptide vaccine for pancreatic cancer (PDAC-WT1).

Scientific Title

Pilot study of WT1 peptide vaccine therapy for chemorefractory advanced pancreatic cancer

Scientific Title:Acronym

Wt1 peptide vaccine for pancreatic cancer (PDAC-WT1).

Region

Japan

Condition

Pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Investigation of the effectiveness of WT1 peptide (mp235-243) vaccine in combination with prior chemortherapy for chemorefractory pancreatic cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Safty and toxicity
Tumor response (Disease control)

Key secondary outcomes

Immune response

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Combination of 8 weeks of WT1 peptide vaccine with concurrent chemotherapy

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Patients witth advanced or recurrent pancreatic cancer that is progressive with standard chemotherapy. Any regimen of prior chemotherapy is acceptalble.
2) Pancreatic cancer should be histologically confirmed and informed to the patient.
3) Patients with HLA-A2402.
4) Any prior surgical treatment, chemotheraphy, radiation therapy, immunotherapy other than WT1 is acceptable.
5) There should be at least two weeks from thea last chemotherapeutic administration.
6) Patients with measreable disease acccording to the RECIST criteria.
7) Patints should be 20-years-old or older and less than 80-years-old.
8) Patients with Karnofsky Performance status of 50 or more.
9) Patients whose survival is expected 3 months or longer.
10) Patients with organ function preserved as indecated below.
WBC >= 3,000/microL and <12,000/microL
Neutrophil >= 1,500/microL
Platelets >= 50,000/microL
Hemoglobin >= 9.0g/dL
AST(GOT), ALT(GPT) < 5x Institutional upper limit.
Total bilirubin <5x Institutional upper limit.
Alubumin >= 2.5g/dL
Creatinin < Instititional Upper Limit
11) Patients with written informed consent on this pilot study.

Key exclusion criteria

1) Patients with uncontrollable infection including active tuberculosis.
2) Patients with severe concurrent disease including malignant hypertension, congestive heart failure, severe coronary disorder, myocardial infarction within 3 months, severe liver cirrhosis, uncontrollable diabetes mellitus, lung fibrosis, interstitial pneumonia, prominent peripheral edeme.
3) Patients who showed severe complication (Grade 3 or more severe according to CTCAE version 3.0) with prior chemotherapy.
4) Patients who require 24 h or more intravenous, transcatheteric nutrition or total parenteral nutrition due to GI symptom.
5) Patients with double cancer.
6) Patients with myelo-dysplastic syndrome or myeopoliferative disease.
7) Pregnant or supposed to be pregnant patient.
8) Patients with past history of severe drug allergy.
9) Patients with severe mental disorder.
10) Patients who is not recommended by attending physician, or trial conductor.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Egawa

Organization

Tohoku University Hospital

Division name

Division of Hepato-Biliary-Pancreatic Surgery

Zip code

Address

1-1 Seiryo Aoba, Sendai 980-8574, JAPAN

TEL

022-717-7205

Email

Name of contact person

1st name
Middle name
Last name	Shinichi Egawa

Organization

Tohoku University Hospital

Division name

Division of Hepato-Biliary-Pancreatic Surgery

Zip code

Address

1-1 Seiryo Aoba, Sendai 980-8574, JAPAN

TEL

022-717-7205

Homepage URL

Email

Institute

Tohoku University Hospital

Institute

Department

Personal name

Organization

Japan Society for Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

11

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2008

Year

09

Month

22

Day

Date of IRB

Anticipated trial start date

2009

Year

01

Month

01

Day

Last follow-up date

2010

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

11

Month

19

Day

Last modified on

2011

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001824