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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002856
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Devision of Clinical Oncology, Tohoku University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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