UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004641 |
|---|---|
| Receipt number | R000005536 |
| Scientific Title | Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2015/06/01 14:06:25 |
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Basic information
Public title
Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer
Acronym
Phase II clinical trial of peptide vaccination with chemotherapy in patients with unresectable advanced pancreatic cancer
Scientific Title
Phase II clinical trial of peptide vaccination with HLA-A2402-restricted KIF20A and VEGFR1 epitope peptides with gemcitabine chemotherapy in patients with unresectable advanced pancreatic cancer
Scientific Title:Acronym
Phase II clinical trial of peptide vaccination with chemotherapy in patients with unresectable advanced pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate clinical efficacy with Gemicitabine plus peptide vaccine therapy in patients with unresectable advanced pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
Gemcitabine is administered at a dose of 1000 mg/m2 on days 1, 8, and 15 in a 28-day cycle. KIF20A and VEGFR1 peptides are subcutaneously injected weekly at each doses of 2 mg/body in patients with HLA-A*2402-positive group.
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. Patients who have unresectable advanced pancreatic cancer before undergoing chemotherapy or vaccination.
2. Performance status (ECOG) of the patients are 0-2.
3. more than 20, less than 80 years of age.
4. The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
5. Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
6. Patients who can expect the survival of three months or more.
7. WBC count more than 3500/mm3, less than 10000/mm3. Plt count more than 100000/mm3. AST and ALT less than 150IU/L. T-Bil less than 2.0mg/dl. Creatinine less than 1.5mg/dl.
8. All patients gave written informed consent.
Key exclusion criteria
1. Patients have uncontrollable associated cancer.
2. Patients have uncontrollable severe infectional diseases.
3. Patients have severe trauma.
4. Patients who are treated with steroid or immunotherapy during clinical trial.
5. Pregnancy or lactation.
6. Patients who have non-recovered injury.
7. Patients judged inappropriated by doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Watanabe |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
sumio@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Kato |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
jun-kato@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 12 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2015 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005536
