UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002408
Receipt No. R000002952
Scientific Title Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.
Date of disclosure of the study information 2009/09/01
Last modified on 2009/08/31

* 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 study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.
Acronym Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.
Scientific Title Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.
Scientific Title:Acronym Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Breast Cancer to Chemotherapy.
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate safety and adverse effect on cancer vaccination therapy using three tumor-associated antigen peptides in patient with refractory breast cancer to chemotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Evaluation of safety and adverse effect of vaccination therapy
Key secondary outcomes

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 Three peputides restricted to HLA-A*2402(1.0mg for each)are administered 12 times once a week.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1.Advanced breast cancer which is refractory to any chemotherapy.
2.Age between 20 to 85
3.ECOG performance status 0-2
4.WBC > 3000/mm3
Platelet > 75000/mm3
Hemoglobon > 9.0g/dL
Serum creatinine <2.0mg/dL
Asparate transaminase > 120 IU/L
Alanine transaminase > 120 IU/L
Total bilirubin < 2.5mg/dL
5.More than 4 weeks later after treatment(chemotherapy/radiotherapy etc)
6.Life expectancy > 3 manths
7.HLA-A*2402
8.Have a lesion which can be measured by CT/MRI
9.Able and willing to give valid written informed cansent
Key exclusion criteria 1.No uncontrollable infections
2.No curative traumatic wound
3.No uncontrollable ulcera
4.No abnormal coagulation
5.Concurrent treatment with acetylsalicylic acid and/or NSAIDs
6.No thrombosis
7.No severe complications (heart failure etc)
8.No other malignancy requiring treatment
9.Concurrent treatment with steroids or immunosuppressing agent
10.No Psychosis
11.Pregnancy/Breast feeding
12.Decision of unsuitableness by principal investigator or physician in change
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsue Saito
Organization Juntendo University School of Medicine
Division name Department of Breast and Endocrine Surgery
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University School of Medicine
Division name Department of Breast and Endocrine Surgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Breast and Endocrine Surgery, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Juntendo 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
2009 Year 09 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 Enrolling by invitation
Date of protocol fixation
2009 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 31 Day
Last modified on
2009 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002952

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.