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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001844
Receipt No. R000002216
Scientific Title Phase II clinical trial of personalized peptide vaccination for advanced breast cancer
Date of disclosure of the study information 2009/04/05
Last modified on 2019/01/07

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Basic information
Public title Phase II clinical trial of personalized peptide vaccination for advanced breast cancer
Acronym Peptide vaccination for advanced breast cancer
Scientific Title Phase II clinical trial of personalized peptide vaccination for advanced breast cancer
Scientific Title:Acronym Peptide vaccination for advanced breast cancer
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Up to 4 from the 31 candidate peptides, to which peptide specific immunoglobulin g are detected before vaccination,are administered to standard therapy failed
breast cancer patients. The aim of the study is to investigate immunological response.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination.
Key secondary outcomes 1. Evaluation of long-term prognosis (progression free survival and total survival).
2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC.

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 (1st treatment: total 6 times, every weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
Day 8, 15, 22, 29, 36: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 45: Final evaluation.
The 1st treatment (total 6 times, every weeks) is finished
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 The subjects must be satisfactory the following conditions.

1 patients must be diagnosed as breast cancer. The patients must be suffering from cervical cancer after the standard therapy.
2 patients must be positive for HLA-A2,A24,A26 or A3 supertype.
3 patients must have immunoglobulin g reactive to at least two of candidate peptides.
4 patients must be at a score level 0-1 of performance status.
5 patients must be expected to survive more than 3 months.
6 Patients must satisfy the followings
WBC is more than 2500 per mm3
Lymphocyte is more than 1000 per mm3
Hb is more than 8 g per dl
Platelet is more than 80000 per mm3
Serum creatinine is less than 2 times
upper limit of normal
Total bilirubin is less than 2 times upper limmit of normal
7 patients must be more 20 year old.
8 written informed consent must be obtained from patients.

Key exclusion criteria The following patients must be excluded

1. Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2. Patients with the past history of severe allergic reactions.
3. Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4. Patients who are judged inappropriate for the clinical trial by doctors.


Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uhi Toh
Organization Kurume university medical school
Division name Dept. of surgery
Zip code
Address Asahi-machi 67, Kurume, Fukuoka 830-0011
TEL 0942-31-7612
Email utoh@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization kurume university
Division name Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Zip code
Address Asahi-machi 67, Kurume, Fukuoka 830-0011
TEL 0942-31-7744
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 04 Month 05 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
2009 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 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 04 Month 02 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002216

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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