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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000027279
Receipt No. R000031257
Scientific Title Open-labeled, non-randomized, single institute study to evaluate safety and efficacy of dendritic cell vaccination using artificial antigens or tumor lysate for patients with advanced malignancies.
Date of disclosure of the study information 2017/05/09
Last modified on 2019/06/17

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Basic information
Public title Open-labeled, non-randomized, single institute study to evaluate safety and efficacy of dendritic cell vaccination using artificial antigens or tumor lysate for patients with advanced malignancies.
Acronym Dendritic cell vaccination for patients with advanced malignancies
Scientific Title Open-labeled, non-randomized, single institute study to evaluate safety and efficacy of dendritic cell vaccination using artificial antigens or tumor lysate for patients with advanced malignancies.
Scientific Title:Acronym Dendritic cell vaccination for patients with advanced malignancies
Region
Japan

Condition
Condition Patients with advanced malignancies
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Obsterics and gynecology Oto-rhino-laryngology Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to investigate safety and efficacy of dendritic cell vaccination using artificial antigens or tumor lysate for patients with refractory or relapsed advanced malignancies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Adverse events and Efficacy
Key secondary outcomes Immunological response,Progression free survival, Overall 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
Interventions/Control_1 Patients are injected intradermally at axilla or inguinal region with dendritic cells pulsed with artificial antigens or tumor lysate (approximately 1x107). At the same time, OK432 (0.5-3KE) is injected subcutaneously in the vicinity of dendritic-cell-injected site. Injection of dendritic cells is performed every two weeks seven times. WT1 peptide (HLA-A*2402-restricted, modified p235-243 peptide or HLA-A*0201-restricted p126-134 peptide) and MUC1 peptide are employed for artificial antigens. Safety and efficacy are evaluated after seventh DC vaccination.
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. Patients with advanced or relapsed malignancies
2. Having evaluable disease by RECIST criteria
3. Performance Status; 0-2
4. Survival period is expected more than 4 months
5. Meet the following criteria for organ functions
1) WBC more than 2,500/microliter, Hemoglobin more than 9.0 g/dl, Platelet more than 90,000/microliter
2) Serum AST/ALT less than 2.5 folds of the upper normal limit
3) Serum bilirubin less than1.5 folds of the upper normal limit
4) Serum Albumin more than 3.0g/dl
5) Serum creatinine within normal limitation
6. Patients can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells.
7. HLA-A*2402, 0201 or 0206 positive (WT1 DC)
8. Informed consent has been obtained.
Key exclusion criteria 1. There is deep-seated active infection.
2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis.
3. Patients who have complications are considered inappropriate for the trial.
4. There are other malignancies.
5. Pregnant or lactating woman.
6. Past history of severe drug allergy.
7. There is severe psychiatric disease.
8. The patient is considered inappropriate for the trial by a responsible doctor.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Ogasawara
Organization Sapporo Hokuyu Hospital
Division name Dept. of Internal Medicine
Zip code
Address 6-6-5-1 Higashisapporo Shiroishiku Sapporo
TEL 011-865-0111
Email ogasawara@hokuyu-aoth.org

Public contact
Name of contact person
1st name
Middle name
Last name Ikumi Yamada
Organization Sapporo Hokuyu Hospital
Division name Cellular Immunotherapy Center
Zip code
Address 6-6-5-1 Higashisapporo Shiroishiku Sapporo
TEL 011-865-0111
Homepage URL
Email i.yamada0414@hokuyu-aoth.org

Sponsor
Institute Sapporo Hokuyu Hospital
Institute
Department

Funding Source
Organization Sapporo Hokuyu Hospital
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 05 Month 09 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 Suspended
Date of protocol fixation
2009 Year 03 Month 17 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
2017 Year 05 Month 09 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031257

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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