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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003255
Receipt No. R000003936
Scientific Title Clinical study using denderitic cell vaccinations for cancer patients
Date of disclosure of the study information 2010/04/01
Last modified on 2013/08/26

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Basic information
Public title Clinical study using denderitic cell vaccinations for cancer patients
Acronym Clinical study using denderitic cell vaccinations for cancer patients
Scientific Title Clinical study using denderitic cell vaccinations for cancer patients
Scientific Title:Acronym Clinical study using denderitic cell vaccinations for cancer patients
Region
Japan

Condition
Condition Malignancy
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a multidisciplinary cancer therapy, we aim at developing a dendritic cell vaccine therapy to complement surgery, radiotherapy, and chemotherapy. A combination of dendritic-cell vaccine therapy and low-dose chemotherapy (dormant chemotherapy or metronome therapy) or minimally-invasive radiotherapy has a possibility of becoming a standard cancer therapy in the future.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The size of a measurable lesion is determined before and after therapy using various diagnostic imaging methods, such as CT, MRI, US, and PET. The sum of the longest diameters is calculated and evaluated based on the RECIST guideline as follows:
- Complete Response (CR): Disappearance (confirmed at 4 weeks)
- Partial Response (PR): ≥30% reduction (confirmed at 4 weeks)
- Stable Disease (discontinuation of disease progression): Neither PR nor PD criteria are met.
- Progressive Disease (PD): ≥20% increase (not diagnosed as CR, PR, or SD before the increase of a lesion)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Dendritic cell vaccine therapy
A vaccine of 10000000 dendritic cells per injection is transfused intradermally around the regional lymph node. The vaccine is injected intradermally every other week 1-7 times. Simultaneously, 1-5 KE picibanil is administered subcutaneously as an adjuvant around the injection site.
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 cancer intractable to standard therapies, including surgery, radiotherapy, and chemotherapy.
2) Patients with progressive cancer (stage III or IV) representing metastasis.
3) Patients with recurrent cancer after the completion of standard therapy.
4) Patients with cancer at high risk of relapse, who hope for the combined use of dendritic cell therapy as a standard therapy.
5) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
6) Patients without severe organ dysfunction, infection, dysemia, and a bleeding tendency.
7) Patients without cardiovascular disorders, who can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells.
8) An excised tumor sample large enough to prepare a tumor cell lysate in order to conduct autologous dendritic cell therapy for cancer.
9) Informed consent to conduct this therapy as a medical treatment at the patient's own expense.
Key exclusion criteria 1) Pregnant or lactating women
2) &#8805;100 IU/l ALT or AST before the start of therapy
3) <50,000 platelet count
4) Allergy to penicillin or picibanil
5) Patients judged ineligible for the therapy by an attending physician
6) Juveniles
7) Adults with impaired judgment
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Maejima1), Nobuyuki Udagawa2)
Organization Matsumoto Dental University
Division name 1)Internal Medicine, 2)Oral Biochemistry
Zip code
Address 1780 Gobara, Hirooka, Shiojiri, Nagano
TEL 070-5014-3303
Email udagawa@po.mdu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Megumi Tanaka
Organization Matsumoto Dental University
Division name Matsumoto Dental University Hospital
Zip code
Address 1780 Hiro-oka Gobara, Shiojiri, Nagano, Japan
TEL 0263-51-2353
Homepage URL
Email mtanaka@po.mdu.ac.jp

Sponsor
Institute Matsumoto Dental University
Institute
Department

Funding Source
Organization None
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
2010 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2010 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2010 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 02 Month 24 Day
Last modified on
2013 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003936

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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