UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001286 |
|---|---|
| Receipt number | 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 18:03:43 |
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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
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
kageyama@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University, University of Ocupational and Environmental Health, Nagasaki University, National Hospital Organization Saga National Hospital, Hamamatsu Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001545
