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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002857
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tohoku University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003486

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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