UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003613 |
|---|---|
| Receipt number | R000004379 |
| Scientific Title | Cancer vaccine in combination with down-modulation of regulatory T cells for patients with incurable cancer |
| Date of disclosure of the study information | 2010/05/14 |
| Last modified on | 2013/11/13 09:30:58 |
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Basic information
Public title
Cancer vaccine in combination with down-modulation of regulatory T cells for patients with incurable cancer
Acronym
SimVac
Scientific Title
Cancer vaccine in combination with down-modulation of regulatory T cells for patients with incurable cancer
Scientific Title:Acronym
SimVac
Region
| Japan |
Condition
Condition
Non-small cell lung cancer, Gastric cancer, Esophageal cancer, Colon cancer, Pancreatic cancer, Breast cancer
Classification by specialty
| Gastroenterology | Pneumology | Hematology and clinical oncology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase II trial of cancer vaccine in combination with basiliximab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tumor response and safety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
peptide vaccine 0.3mg
Interventions/Control_2
peptide vaccine 3mg
Interventions/Control_3
anti-CD25 antibody (+)
Interventions/Control_4
anti-CD25 antibody (-)
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
Standard therapy failure, no standard therapy, HLA-A24, Sufficient organ function, Measurable lesion
Histologically-defined incurable esophageal, colon, lung, pancreatic, gastric, and breast cancers
Age 20-80
PS 0-2
Estimated prognosis >= 3 months
WBC>4,000/mm3, <12,000/mm3
NE>2,000/mm3
PLT>100.000/mm3
Hg>10.0g/dl
GOT/GPT<Normal range x 2
Bil<1.5mg/dl
Creat<1.5mg/dl
Key exclusion criteria
Autoimmune disease
Uncontrollable complication
infection, diabetes, hypertension, ischemic heart disease, cerebral infarction
Pregnancy
Allergy
Interstitial lung disease
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki YAMAGUCHI |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
Address
Matsushima 577, Kurashiki, Okayama 701-0192, Japan
TEL
086-462-1111
shogo@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki YAMAGUCHI |
Organization
Kawasaki Medical School
Division name
Department of Clinical Oncology
Zip code
Address
matsushima 577, Kurashiki-city, Okayama, 701-0192 Japan
TEL
086-462-1111
Homepage URL
kasco@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
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 | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 13 | Day |
Last modified on
| 2013 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004379
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
