UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001903 |
|---|---|
| Receipt number | 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 12:58:24 |
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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
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
gliomadc@onh.go.jp
Sponsor or person
Institute
Osaka National Hospital, National Hospital Organization
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002276
