UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002136
Receipt number R000002608
Scientific Title Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma
Date of disclosure of the study information 2009/07/02
Last modified on 2016/01/29 13:36:58

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Basic information

Public title

Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma

Acronym

Autologous tumor lysate-pulsed dendritic cell therapy for advanced renal cell carcinoma

Scientific Title

Safety, efficacy and immunogenicity of autologous tumor lysate-pulsed dendritic cell therapy in patients with advanced renal cell carcinoma

Scientific Title:Acronym

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 on combination therapy of autologous tumor lysate- pulsed dendritic cell vaccination and sunitinib 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 cell
Sunitinib

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 sunitinib 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;
- Performance status is 0-2;
- No serious abnormality in heart, lung, bone marrow, liver, and renal functions.

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 cancers.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukio Homma

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

03-5800-8662

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiro Kakimi

Organization

Graduate School of Medicine, The University of Tokyo

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 or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

Medinet Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2009 Year 07 Month 02 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Journal for ImmunoTherapy of Cancer.2014,2:30

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

Completed

Date of protocol fixation

2009 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date

2015 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 06 Month 29 Day

Last modified on

2016 Year 01 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002608


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name