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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001903
Receipt No. R000002276
Scientific Title Clinical study to investigate safety and efficacy on autologous tumor lysate-pulsed dendritic cells
Date of disclosure of the study information 2009/05/01
Last modified on 2013/04/30

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Basic information
Public title Clinical study to investigate safety and efficacy on autologous tumor lysate-pulsed dendritic cells
Acronym Clinical study to investigate safety and efficacy on autologous tumor lysate-pulsed dendritic cells
Scientific Title Clinical study to investigate safety and efficacy on autologous tumor lysate-pulsed dendritic cells
Scientific Title:Acronym Clinical study to investigate safety and efficacy on autologous tumor lysate-pulsed dendritic cells
Region
Japan

Condition
Condition Malignant Glioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and efficacy on combination temozolomide and autologus tumor lysate-pulsed dendritic cells for malignant glioma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes Antitumor effect
Progression-free survival
Overall survival
QOL
Immunological responses

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
Interventions/Control_1 Tumor lysate-pulsed dendritic cell
temozolomide
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 Malignant Glioma patients who have:
1)Measurable lesion or after surgical resection of recurrent lesion.
2)Patient's tumor tissue.
3)20 years or more.
4)More than 3 months since prior external beam radiotherapy.
5)No serious abnormality in bone marrow. liver and/or renal functions.
Key exclusion criteria 1)Pulmonary fibrosis or interstitial pneumonia, or their history, or predisposition to them
2)Serious drug allergy
3)Positive for hepatitis B, C, HIV-1, 2, HTLV-1 or syphilis
4)Serious cardiac disease
5)Active autoimmune diseases
6)Other cancers
7)Uncontrollable infection
8)Pregnancy or lactation
9)Gelling of plasma, cryogloblinemia
10)Any reason why, in the opinion of the investigator, the patient should not participate
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yonehiro Kanemura
Organization Osaka National Hospital,
National Hospital Organization
Division name Institute for Clinical Research
Zip code
Address 2-1-14 Hoenzaka Chuo-ku, Osaka540-0006, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yonehiro Kanemura
Organization Osaka National Hospital, National Hospital Organization
Division name Institute for Clinical Research
Zip code
Address 2-1-14 Hoenzaka Chuo-ku, Osaka540-0006, Japan
TEL
Homepage URL
Email gliomadc@onh.go.jp

Sponsor
Institute Osaka National Hospital, National Hospital Organization
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
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 独立行政法人国立病院機構 大阪医療センター(大阪府)

Other administrative information
Date of disclosure of the study information
2009 Year 05 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 Completed
Date of protocol fixation
2009 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 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 04 Month 24 Day
Last modified on
2013 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002276

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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