UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002857 |
|---|---|
| Receipt number | R000003486 |
| Scientific Title | Phase II study of peptide vaccination for patients with metastatic lung or gastro-intestinal tract cancers |
| Date of disclosure of the study information | 2009/12/07 |
| Last modified on | 2011/12/08 15:31:17 |
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Basic information
Public title
Phase II study of peptide vaccination for patients with metastatic lung or gastro-intestinal tract cancers
Acronym
Phase II study of peptide vaccination for patients with metastatic cancers
Scientific Title
Phase II study of peptide vaccination for patients with metastatic lung or gastro-intestinal tract cancers
Scientific Title:Acronym
Phase II study of peptide vaccination for patients with metastatic cancers
Region
| Japan |
Condition
Condition
lung cancer, pharyngeal cancer, gastric cancer, jejunal cancer, ileal cancer, pancreas cancer, biliary tract cancer,
soft tissue sarcoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to search for efficacy of cancer specific antigen-derived or VEGFR1/2-derived peptide vaccines among various human cancers. This is clinical study collaborated with Prof. Yusuke Nakamura, Institute of Medical Science, the University of Tokyo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluation of efficacy by RECIST criteria
Key secondary outcomes
Overall survival, Responsive rate, TTF, Immunological responses by peptide vaccination (CTL, CD8, regT)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
peptide vaccinnation
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) clinically and pathologically diagnosed lung cancer, pharyngeal cancer, esophageal cancer, gastric cancer, pancreas cancer, bile duct cancer, intestinal cancer, or colon cancer
2) obtains lesion(s) that can be evaluated by RECIST.
3) refractory for standard therapies
4) Performance status (ECOG) 0 or 1
5) more tha 4 weeks after prior therapy
6) WBC >=3,000
lymphocytes>=1,000
Hb>=9.0
Platelet>=100,000
Serum creatinine<=1.4
Total bilirubin <=1.5
7) obtains written informed consent
Key exclusion criteria
1) HIV positive patients
2) severe comorbidity (respiratory disease, immunological disease, coagulation disorders, etc)
3) pregnant woman
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Mori |
Organization
Tohoku University Hospital
Division name
Cancer Center
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Hospital
Division name
Department of Clonical Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Oncology
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
| 2009 | Year | 12 | Month | 07 | 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
| 2008 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 07 | Day |
Last modified on
| 2011 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003486
