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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001286
Receipt No. R000001545
Scientific Title clinical trial of CHP-HER2 cancer vaccine with immuno-adjuvant, OK-432, for advanced breast cancer
Date of disclosure of the study information 2008/08/02
Last modified on 2012/08/28

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Basic information
Public title clinical trial of CHP-HER2 cancer vaccine with immuno-adjuvant, OK-432, for advanced breast cancer
Acronym CHP-HER2 vaccine for advanced breast cancer
Scientific Title clinical trial of CHP-HER2 cancer vaccine with immuno-adjuvant, OK-432, for advanced breast cancer
Scientific Title:Acronym CHP-HER2 vaccine for advanced breast cancer
Region
Japan

Condition
Condition Resected locally-advanced breast cancer
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess immune responses in HER2-positive resected locally advanced breast cancer patinets who have given cholestryl pullulan(CHP)-HER2 protein vaccine.
Basic objectives2 Others
Basic objectives -Others To explore the immune responsess and the disease reccurence
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes HER2-specific immune responses
Key secondary outcomes Time to reccurence
Adverse events

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
Medicine Vaccine
Interventions/Control_1 CHP-HER2 300microgram, OK-432 0.2KE, subcutaneous injection, q2wks x12 doses, followed by booting doses with three-month interval.
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 Female
Key inclusion criteria Clinical stage IIIA or IIIB(UICC-TNM classification) histoligically confirmed primary breast cancer, which expresses 2+ or 3+ HER2, scored by HercepTest.
Negative both for estrogen and progesteron receptors.
Lating 4 to 12 weeks from surgery, chemotherapy, and radiotherapy, and confirmed as disease-free.
One year or less lating from tumor resection.
Performance status(ECOG) 0 or 1.
Neutrophil counts 1,500/uL or more.
Lymphocytes 500/uL or more.
Platelets 100,000/uL or more.
Hemoglobin 9.0 g/dl or more.
Serum creatinine 1.8 mg/dl or less.
Serum bilirubin 2.0mg/dl or less.
AST(GOT)/ALT(GPT) both 100 IU/L or less.
Having written informed consent.
Key exclusion criteria Previous uses of trastuzumab(Herceptin).
Uncontrolled heart failure.
Impaired cardiac function, 50% or less of ejection fraction.
Uncontrolled arrythmia.
Uncontrolled hypertention.
Angina pectoris, cardiac valvular disease.
Pulmonary fibrosis.
Uncontrolled diabetes mellitus.
Antibody-requiring active infection.
Blood clotting disorder.
Positive for HBV, HIV or HTLV-1, except HBV healthy carrier and negatives for HCVmRNA.
History of penicillin allergy.
Ongoing corticosteroid therapy.
Pregnancy
Willing to be pregnant.
Inappropriate for study entry judged by an attending physician.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Shiku
Organization Mie University Graduate School of Medicine
Division name Department of Cancer Vaccine/Immuno-Gene Therapy
Zip code
Address 2-174, Edobashi, Tsu, Mie, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kageyama
Organization Mie University Graduate School of Medicine
Division name Department of Cancer Vaccine/Immuno-Gene Therapy
Zip code
Address
TEL
Homepage URL
Email kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University, University of Ocupational and Environmental Health, Nagasaki University, National Hospital Organization Saga National Hospital, Hamamatsu Medical Center
Institute
Department

Funding Source
Organization Cancer Translational Research, Ministry of Education, Culture, Sports, Science and Technology, and othrs
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
2008 Year 08 Month 02 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 Terminated
Date of protocol fixation
2006 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 07 Month 01 Day
Date trial data considered complete
2010 Year 07 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 08 Month 02 Day
Last modified on
2012 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001545

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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