UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003945 |
|---|---|
| Receipt number | R000004749 |
| Scientific Title | A phase 1 study of adoptive immunotherapy using autologous RNF43 peptide pulse dendritic cells and RNF43 peptide specifically activated lymphocytes in patients with advanced solid tumors |
| Date of disclosure of the study information | 2010/07/25 |
| Last modified on | 2014/09/17 10:53:35 |
* 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
A phase 1 study of adoptive immunotherapy using autologous RNF43 peptide pulse dendritic cells and RNF43 peptide specifically activated lymphocytes in patients with advanced solid tumors
Acronym
RNF43 peptide pulse DC with specifically activated lymphocytes therapy
Scientific Title
A phase 1 study of adoptive immunotherapy using autologous RNF43 peptide pulse dendritic cells and RNF43 peptide specifically activated lymphocytes in patients with advanced solid tumors
Scientific Title:Acronym
RNF43 peptide pulse DC with specifically activated lymphocytes therapy
Region
| Japan |
Condition
Condition
advanced solid tumors which already have finished available standard therapies.
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Surgery in general |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate saftey and efficacy of RNF43 peptide pulse DC with specifically activated lymphocytes therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
safety
Key secondary outcomes
clinical efficacy and immunologic monitoring
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
First cohort; five patinets
1.RNF43 peptide specifically activated autologous lymphocytes infusion
5x10^7 cells, single dose, i.v.
2.RNF43 peptide pulse DC administration
on day 1,8 and 15
Interventions/Control_2
Second cohort; five patinets
1.RNF43 peptide specifically activated autologous lymphocytes infusion
2x10^8 cells, single dose, i.v.
2.RNF43 peptide pulse DC administration
on day 1,8 and 15
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Advanced solid tumors which already have finished available standard therapies.
2. Performance status 0-1 (ECOG).
3.HLA-A2402 or A0201-positive status.
4. PCR-confirmed RNF43-antigen expression of tumor cells
5.Having measurable tumor for assessing clinical responses
6.Patients who have recovered from the toxicity of any previous therapy for at least 4 weeks before trial entry.
7.Life expectancy of at least 3 months.
8.Adequate hematological function
WBC count more than 3000 /uL,
platelet count more than 100000/uL,
AST, ALT less than 3 X ULN value,
T-Bil less than 2.0mg/dl,
s-Cr less than 1.5mg/dl.
9.Negative for hepatitis B antigen, anti-hepatitis C antibody, anti-HIV antibody, anti-HTLV-1 antibody and syphilis serodiagnosis.
10.Written informed consent obtained at the time of enrolment.
Key exclusion criteria
1.Patients with severe pre-exiting diseases :autoimmune diseases, an active
infectious diseases, cardiovascular disorders, respiratory disorders, renal dysfunction, immunodeficiency, and hematological disorders.
2.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner
3.No active brain metastases.
4.Patients who should receive systemic administration of steroid or
immunosuppressive agents.
5.Inappropriate for study entry judged by an attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenzaburo Tani |
Organization
Kyushu University Hospital
Division name
Department of Advanced Molecular and Cell Therapy
Zip code
Address
3-1-1 Maidashi, Higashiku, Fukuoka-shi, 812-8582, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuki Hijikata |
Organization
Kyushu University Hospital
Division name
Department of Advanced Molecular and Cell Therapy
Zip code
Address
3-1-1 Maidashi, Higashiku, Fukuoka-shi, 812-8582, Japan
TEL
092-642-5996
Homepage URL
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
| 2010 | Year | 07 | Month | 25 | 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 | 19 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 25 | Day |
Last modified on
| 2014 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004749
