UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Akihiko Matsumoto
Organization	The University of Tokyo Hospital
Division name	Department of Urology
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	Kazuhiro Kakimi
Organization	The University of Tokyo Hospital
Division name	Department of Immunotherapeutics
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016972