UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006730 |
|---|---|
| Receipt number | R000007949 |
| Scientific Title | Heat Shock Protein 105 (HSP105) peptide-pulsed dendritic cell vaccination therapy for patients with advanced/ recurrent cancer. |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2014/11/25 11:50:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Heat Shock Protein 105 (HSP105) peptide-pulsed dendritic cell vaccination therapy for patients with advanced/ recurrent cancer.
Acronym
HSP105 peptide-pulsed dendritic cell vaccination therapy for advanced/ recurrent cancer.
Scientific Title
Heat Shock Protein 105 (HSP105) peptide-pulsed dendritic cell vaccination therapy for patients with advanced/ recurrent cancer.
Scientific Title:Acronym
HSP105 peptide-pulsed dendritic cell vaccination therapy for advanced/ recurrent cancer.
Region
| Japan |
Condition
Condition
Advanced/recurrent cancer
(pancreatic cancer, colon cancer, biliary tract cancer, esophageal cancer, pharynx cancer, breast cancer etc.)
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Breast surgery |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of HSP105 peptide-pulsed dendritic cell vaccination therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
Key secondary outcomes
Immunological responses
Antitumor effect
Overall survival
Progression-free survival
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
| Vaccine | Maneuver |
Interventions/Control_1
HSP105 peptide-pulsed dendritic cells are injected on day
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
1) Age >= 20 years at informed consent.
2) Patients who recognized HSP105 expression on tumor tissue.
3) HLA-A*24:02, 02:01, 02:06 or 02:07 positive.
4) Performance status is 0-1.
5) No serious abnormality in heart, lung, bone marrow, liver, and renal functions.
Key exclusion criteria
1) Pulmonary fibrosis or interstitial pneumonia, including their history or predisposition;
2) Serious drug allergy;
3) Difficult infections to control;
4) Serious cardiac disease;
5) Active autoimmune diseases;
6) Other cancers;
7) Continuous systemic administration of steroids and/or immunosuppressants within 4 weeks.
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
The University of Tokyo Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Artificial Organ and Transplantation Surgery Division
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kakimi |
Organization
The University of Tokyo Hospital
Division name
Department of Immunotherapeutics
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5805-3161
Homepage URL
immunotherapy-admin@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2011 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007949
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
