UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007991
Receipt number R000009165
Scientific Title The development of a novel dual-targeting peptide vaccine therapy in patients with resected pancreatic cancer.
Date of disclosure of the study information 2012/06/01
Last modified on 2013/11/24 16:26:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The development of a novel dual-targeting peptide vaccine therapy in patients with resected pancreatic cancer.

Acronym

The development of a novel dual-targeting peptide vaccine therapy in patients with resected pancreatic cancer.

Scientific Title

The development of a novel dual-targeting peptide vaccine therapy in patients with resected pancreatic cancer.

Scientific Title:Acronym

The development of a novel dual-targeting peptide vaccine therapy in patients with resected pancreatic cancer.

Region

Japan


Condition

Condition

resected-pancreatic cancer

Classification by specialty

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

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this object is exploratory evaluation of the safety and the efficacy of the OCV-C01 peptide vaccine containing OTS102, OCV-101, and OCV-105 peptide vaccine combined with gemcitabine in resected pancreatic cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

disease-free survival

Key secondary outcomes

survival


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

Medicine

Interventions/Control_1

OCV-C01 1mL will be administered by subcutaneous injection on days, 1,8,15 and 22 of each 28-day treatment cycles for 48 weeks.
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days,1,8 and 15 for 24 weeks.

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) Invasive pancreatic ductal carcinoma histologically confirmed as papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma or adenosquamous carcinoma of the pancreas.
(2) Histologically confirmed R0 or R1 resected invasive pancreatic ductal carcinoma.
(3) No recurrence
(4) No Prior treatment for pancreatic cancer except surgical resection.
(5) Patients must have Human Leukocyte Antigen (HLA)-A*24:02.
(6) Patients must be >=20 years old and <=80 years old at the time of consent.
(7) ECOG Performance Status must be 0 or 1.
(8) The following criteria must be satisfied in laboratory tests.
1) White blood cell count >=3,500/mm3
2) Neutrophil count >=2,000/mm3
3) Hemoglobin >= 9.0 g/dL
4) Platelet count >=100,000mm3
5) Total bilirubin <=2.0 mg/dL
6) AST <=150 IU/L
7) ALT <=150 IU/L
8) Serum Creatinine <=1.5 mg/dL

(9) No abnormal findings requiring treatment in the electrocardiogram within 21 days before enrollment.

(10) Patients must be enrolled more than 2 weeks elapsed from resection of pancreatic cancer, not to exceed 10 weeks.

(11) Patients must have signed the consent form.

Key exclusion criteria

(1) Interstitial pneumonia or pulmonary fibrosis.
(2) Patients who require systemic administration of the following agents during the study treatment period.
1.Corticosteroid
2.Immunosuppresant, Immunostimulant
(3) Active infections.
(4) Severe complication (heart failure, renal failure, liver failure, bleeding from digestive ulcer, ileus,and uncontrolled diabetes)
(5) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage.
(6) Active double cancer (include asynchronous double cancer with disease-free duration <=3 year) except carcinoma in situ or intramucosal cancer.
(7) Prior treatment of peptide derived from KIF20A, VEGFR-1and VEGFR-2.
(8) Prior cancer treatment except for pancreatic cancer (chemotherapy, hormone therapy, antibody therapy, radiation therapy, immunotherapy, and hyperthermia).
(9) Severe mental disorder.
(10) Sever drug-induced hypersensitivity
(11) Unhealed traumatic lesion, including traumatic fracture.
(12) History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months before administration of OCV-C01.
(13) Need continuous medication of antiplatelet drug except aspirin.
(14) Uncontrolled hypertension.
(15) Heart failure and arrhythmia that needs treatment.
(16) Aneurysms and varices with serious concern of bleeding.
(17) Current participation in other clinical trials.
(18) Patients or partners, who don't attempt to doing contraception during the study period (during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.).
(19) Pregnant females or nursing mothers who can not stop lactation during the recruitment until 120 days after the last administration.
(20) The subject who was determined by investigator that being not adequate to participate in the trial.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Yamaue

Organization

Wakayama Medical University, School of Medicine

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama 641-8510, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Motoki Miyazawa

Organization

Wakayama Medical University, School of Medicine

Division name

Second Department of Surgery

Zip code


Address

811-1 Kimiidera, Wakayama 641-8510, Japan

TEL


Homepage URL


Email

mo-0702@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Cancer Fundation

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2012 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2012 Year 03 Month 02 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 05 Month 20 Day

Last modified on

2013 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009165


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name