UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001295 |
|---|---|
| Receipt number | R000001544 |
| Scientific Title | Phase I trial of CHP-HER2-pulsed dendritic cell vaccine for advanced breast and non-small cell lung cancer |
| Date of disclosure of the study information | 2008/08/04 |
| Last modified on | 2009/08/07 09:35:04 |
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Basic information
Public title
Phase I trial of CHP-HER2-pulsed dendritic cell vaccine for advanced breast and non-small cell lung cancer
Acronym
CHP-HER2 dendritic cell vaccine
Scientific Title
Phase I trial of CHP-HER2-pulsed dendritic cell vaccine for advanced breast and non-small cell lung cancer
Scientific Title:Acronym
CHP-HER2 dendritic cell vaccine
Region
| Japan |
Condition
Condition
breast cancer, non-small cell lung 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 safety of CHP-HER2-pulsed dendritic cell vaccine for advanced/metastatic breast and non-small cell lung cancer patients.
Basic objectives2
Others
Basic objectives -Others
To explore HER2-speficic immune responses and clinical anti-tumor responses.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse effect profiles, including events, frequency and grades.
Key secondary outcomes
HER2-specific immune responses
anti-tumor effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
subcutaneous injection of CHP-HER2-pulsed dendritic cells
each cell dose, 0.3x10E7, 1x10E7, 3x10E7
four doses every two weeks
three subjects for each cell dose, dose-escalating study
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Either of breast cancer or non-small cell lung cancer patients, who have standard-therapy-refractory disease with unrescteable stage III, IV or metastatic lesions.
Performanec status 0 to 2.
Aged 20 to 75.
Four weeks apart from the previous therapy, including surgery, chemotherapy, radiation therapy, heat therapy and other immuno-therapy.
Life expectancy of three month or longer.
preserved bone marrow, liver, kidney functions.
HER2-expression of 2+ and 3+.
Not having uncontrolled cardiac disease.
Not having interstial pneumonia.
Not having uncontrolled diabetes mellitus.
Not having auto-immune disease.
Having informed consent.
Key exclusion criteria
Pregnancy, contra-ceptive during trial entry.
Milking.
Serious bleeding tendency.
Risk of thrombosis.
Acitive infection, HIV, HCV and HBV-positives.
Serious pleural effusion, ascites and pericardial effusion.
Probable alternative drug treatment during the trial.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nishimura, Satoshi Kondo, Masaki Mori |
Organization
Hokkaido University, Institute for Genetic Medicine1), Hospital1Hokkaido University Hospital2), Kyushu University Hospital at Beppu3)
Division name
Division of Immunoregulation1), Department of Surgery2,3)
Zip code
Address
Kita-15-Jo, Nishi-7, Kita-ku, Sapporo, Hokkaido, 3-1-1, Tshurumihara, Tsurumi, Beppu, Oita, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Miyamoto1), Fumiaki Tanaka2) |
Organization
Hokkaido University Hospital1), Kyushu University Beppu Medical Center2)
Division name
Department of Surgery1,2)
Zip code
Address
TEL
Homepage URL
m-miyamo@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Kyushu University Hospital at Beppu
Institute
Department
Personal name
Funding Source
Organization
Cancer Translational Research, Ministry of Education, Culture, Sports, Science and Technology, Japan
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 | 04 | 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 | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | 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 | 04 | Day |
Last modified on
| 2009 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001544
