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 |
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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
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
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
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
