UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002408 |
|---|---|
| Receipt number | 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 14:56:06 |
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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
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
Sponsor or person
Institute
Department of Breast and Endocrine Surgery, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002952
