UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000002 |
|---|---|
| Receipt number | R000000001 |
| Scientific Title | Phase I/IIa trial of autologous tumor vaccination in patients with primary glioblastoma |
| Date of disclosure of the study information | 2005/08/01 |
| Last modified on | 2011/01/05 09:53:59 |
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Basic information
Public title
Phase I/IIa trial of autologous tumor vaccination in patients with primary glioblastoma
Acronym
autologous tumor vaccination for glioblastoma
Scientific Title
Phase I/IIa trial of autologous tumor vaccination in patients with primary glioblastoma
Scientific Title:Acronym
autologous tumor vaccination for glioblastoma
Region
| Japan |
Condition
Condition
Glioblastoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of autologous tumor vaccination to prevent recurrence and/or cure residual tumor for patients with glioblastoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Cause-specific 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
| Vaccine |
Interventions/Control_1
autologous tumor vaccination
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) WHO histological grade IV glioblastoma in(GBM)
supratentrial brain without dissemination.
2) Maximum surgical resection was performed.
3) 1.5 g of tumor was reserved in fixed specimen.
4) Karnofsky performance scale is equal to or more than 60 %.
5) 60 Gy of radiation will be performed.
Key exclusion criteria
1) Patients have taken or take corticosteroid or anticancer drug.
2) Patients with high intracranical pressure.
3) Patients with severe myelosupression.
4) Patients with malignant tumor or cancer.
5) Pregnant woman.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomokatsu Hori |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery, Neurological Institute
Zip code
Address
8-1 Kawada-cho Sinjuku-ku Tokyo
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery, Neurological Institute
Zip code
Address
TEL
03-3353-8111
Homepage URL
Sponsor or person
Institute
Tokyo Womens Medical University
Institute
Department
Personal name
Funding Source
Organization
Cell Medicine Cooperation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tsukuba University
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
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 24 patients were treated.Two patients were excluded by the radiation protocol or by the patient's consent. Although grade 1 dermal toxicity was observed at the injected sites in all patients, no grade 2 or higher hematologic or other toxicity was observed. The trial met the prospectively-defined primary endpoints, with 21.4 months median survival time (range 6.1 to 42 months), 40.0% 2-year survival, and 7.6 months median progression-free survival time (PFS, range 2.2 to 25.6 months).The PFS of the patients with greater delayed type hypersensitivity (DTH) reaction (13.9 months) was statistically longer (p<0.01)than that of the patients with weaker DTH reaction (4.3 months).
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
| 2005 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 06 | Month | 01 | Day |
Last modified on
| 2011 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000001
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