UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002856 |
|---|---|
| Receipt number | R000003443 |
| Scientific Title | Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2012/06/08 09:21:02 |
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Basic information
Public title
Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy
Acronym
Phase I/II study of peptide vaccination in combination with TS-1 for metastatic colorectal cancer with KRAS genetic mutation
Scientific Title
Phase I/II study of VEGFR1/2-derived peptide vaccination in combination with a 5-fluorouracil derivative (TS-1) for metastatic colorectal cancer with KRAS genetic mutation as a third-line therapy
Scientific Title:Acronym
Phase I/II study of peptide vaccination in combination with TS-1 for metastatic colorectal cancer with KRAS genetic mutation
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Recommended doses (RD) of VEGFR1/2-derived peptide vaccines as well as concurrent TS-1 are determined in the first step of this study. DCR, RR, OS, DFS, TTP, and AE are estimated in the second step of this study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
First step (clinical phase I)
Primary Endpoint: RD
Second step (clinical phase II)
Primary Endpoint: DCR
Key secondary outcomes
First step (clinical phase I)
Secondary Endpoint: AE, immunological reactions by peptide vaccine (CTL, CD8, reg T)
Second step (clinical phase II)
Secondary Endpoint: RR, OS, PFS, TTF, AE, immunological reactions by peptide vaccine (CTL, CD8, reg T)
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
| Medicine | Vaccine | Gene |
Interventions/Control_1
KRAS genetic sequence, peptide vaccination, TS1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pathologically diagnosed colorectal cancer
2. contains metastatic lesions that can be estimated by RECIST.
3. undertook first-line and second-line therapies that contained oxaliplatin and CPT-11.
4. contains tumor in which KRAS gene codon 12 or 13 is mutated.
5. HLA-A2402
6. PS=0 or 1 (ECOG)
7. written informed consent
8. WBC >= 3,000 and <=12,000
Platelet >=100,000/mm3
lymphocytes >=1,000
GOT(AST) <=100 IU/L
GPT(ALT) <=100 IU/L
Serum Creatinine<= 1.2 mg/dl
Total Bilirubin <=1.5 mg/dl
Creatinine clearance >=50 ml/min (Cock-Gault)
Key exclusion criteria
1. active double cancer(s)
2. undertook radiation therapy for abdominal lesions.
3. HIV-positive patients
4. sever comorbidity (intestinal obstruction, uncontrolled Diabetes M., uncontrolled hypertension, Angina P., liver cirrhosis, pneumonitis, emphysema, etc)
5. allergy for TS1
6. ascites or pleural effusion that needs to be treated
7. patients with bleeding
8. patients treated with fruitosin
9. pregnant woman
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Mori |
Organization
Tohoku University Graduate School of Medicine
Division name
Cancer Center
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
22-717-7879
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Hospital
Division name
Clinical oncology
Zip code
Address
TEL
022-717-7087
Homepage URL
Sponsor or person
Institute
Devision of Clinical Oncology, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Devision of Clinical Oncology, Tohoku University Hospital
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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | 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
| 2009 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | 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
| 2012 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003443
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