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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003945
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kyushu University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004749

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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