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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014703
Receipt No. R000016972
Scientific Title Safety, efficacy and immunogenicity of concomitant molecular target drug or cytokine therapy and autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma
Date of disclosure of the study information 2014/07/29
Last modified on 2019/01/31

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Basic information
Public title Safety, efficacy and immunogenicity of concomitant molecular target drug or cytokine therapy and autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma
Acronym Clinical study of combined molecular target drug or cytokine therapy and autologous tumor lysate-pulsed dendritic cell therapy for advanced renal cell carcinoma
Scientific Title Safety, efficacy and immunogenicity of concomitant molecular target drug or cytokine therapy and autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma
Scientific Title:Acronym Clinical study of combined molecular target drug or cytokine therapy and autologous tumor lysate-pulsed dendritic cell therapy for advanced renal cell carcinoma
Region
Japan

Condition
Condition Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy of combined molecular target drug or cytokine therapy and autologous tumor lysate-pulsed dendritic cell therapy for advanced renal cell carcinoma.
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
Medicine Vaccine Maneuver
Interventions/Control_1 Tumor lysate-pulsed dendritic cells are injected on days 0, 14, 28, 42, 56 and 70.
Molecular target drug or cytokine are administered in the proper dosage and usage.
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 Renal cell carcinoma patients who undergo surgical resection of primary lesion and receive molecular target drug or cytokine therapy for metastatic lesion:

- Pathological diagnosis of renal cell carcinoma;
- Tumor tissue is preserved after resection of primary lesion and tumor lysate is aseptically prepared;
- Measurable lesion;
- 20 years or more;
- No serious abnormality in heart, lung, bone marrow, liver, and renal functions;
- Written informed consent;

- Outpatients.
Key exclusion criteria Patients who have:
- Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them;
- Serious drug allergy;
- Active infections;
- Serious cardiac disease;
- Active autoimmune diseases;
- Continuous systemic administration of steroids within 4 weeks;
- Other currently active malignancies;

- Women during pregnancy, possible pregnancy, or breast-feeding;
- Brain metastases;
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Matsumoto
Organization The University of Tokyo Hospital
Division name Department of Urology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8648
Email matsumoto-jua@umin.ac.jp

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
Email immunotherapy-admin@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization MEDINET Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Mitsui Memorial Hospital
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 29 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 Terminated
Date of protocol fixation
2014 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 29 Day
Last follow-up date
2018 Year 11 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 29 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016972

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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