UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000775
Receipt number R000000934
Scientific Title Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer
Date of disclosure of the study information 2007/08/01
Last modified on 2007/07/25 23:06:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer

Acronym

Dendritic cell therapy for patients with advanced cancer

Scientific Title

Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer

Scientific Title:Acronym

Dendritic cell therapy for patients with advanced cancer

Region

Japan


Condition

Condition

advanced and recurrent cancer

Classification by specialty

Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Safety and effectiveness

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

safety

Key secondary outcomes

effectiveness


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

cell therapy

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

advanced and recurrent cancer
PS:0-2
No infection
1. 3500<WBC<12,000/cmm
2. platelet>100,000/cmm
3. No severe liver dysfuntion
4. T-Bil<2.0mg/dl
5. UN<25mg/dl
6. Creatinin<1.5mg/dl
7. 24hr Ccr>50ml/min
after completion of informed consent
8. normal ECG

Key exclusion criteria

Pregnancy
Severe Psychiatric disoreder

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ohto Hitoshi

Organization

Fukushima Medical University

Division name

Dept. of Blood transfusion and Transplantation

Zip code


Address

Hikarigaoka 1, Fukushima

TEL

024-547-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Ohto Hitoshi

Organization

Fukushima Medical University

Division name

Dept. of Blood transfusion and Transplantation

Zip code


Address

024-547-1111

TEL


Homepage URL


Email



Sponsor or person

Institute

Fukushima Medical University

Institute

Department

Personal name



Funding Source

Organization

Fukushima Medical University

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

2007 Year 08 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

Date of protocol fixation

2007 Year 07 Month 25 Day

Date of IRB


Anticipated trial start date

2007 Year 08 Month 01 Day

Last follow-up date

2009 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 07 Month 25 Day

Last modified on

2007 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000934


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name