UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007801
Receipt No. R000007478
Scientific Title Phase I/II clinical trial of HLA-A24 restricted epitope peptide cocktail therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Date of disclosure of the study information 2012/04/20
Last modified on 2012/05/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase I/II clinical trial of HLA-A24 restricted epitope peptide cocktail therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Acronym Peptide vaccine therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Scientific Title Phase I/II clinical trial of HLA-A24 restricted epitope peptide cocktail therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Scientific Title:Acronym Peptide vaccine therapy with UFT+LV for patients with advanced metastatic colorectal cancer.
Region
Japan

Condition
Condition Advanced metastatic colorectal cancers
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the safty and in vitro CTL induction of peptides cocktail (RNF43, TOMM34, FOXM1, MELK, HJURP, VEGFR1, VEGFR2) with UFT+LV for HLA-A24 positive patients with advanced metastatic colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Safty
Immunological response
(in vitro CTL induction)
Key secondary outcomes Progression free survival
Overall survival
Data related to tumor regression
Tumor marker (CEA) profile

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Subcutaneous injection of cancer vaccine (seven peptides)
UFT+LV
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 Standard therapies failured metastatic
colorectal cancers.
2 Performance status 0 - 2
3 More than 4 weeks after previous
therapy.
4 WBC >= 2000, Platelet >= 50000,
GOT GPT <= 150, T.bil <= 3, Cr <= 3
5 HLA-A24 positive
6 Informed consent
Key exclusion criteria Pregnant
Lactation
Prognosis >= 3 months
Active infectious disease
Systemic use of steroid hormones or
immunosuppressive drugs.
Others (Doctors judges)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyotaka Okuno
Organization Kinki University School of Medicine
Division name Department of Surgery
Zip code
Address 377-2 Ohnohigashi, Osakasayama, Osaka 589- 8511, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumiaki Sugiura
Organization Kinki University School of Medicine
Division name Department of Surgery
Zip code
Address 377-2 Ohnohigashi, Osakasayama, Osaka 589- 8511, Japan
TEL
Homepage URL
Email

Sponsor
Institute Kinki University School of Medicine
Institute
Department

Funding Source
Organization Kinki 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
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

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 20 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 No longer recruiting
Date of protocol fixation
2011 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 09 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
2012 Year 04 Month 20 Day
Last modified on
2012 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007478

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.