UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001426 |
|---|---|
| Receipt number | R000001734 |
| Scientific Title | Phase I/IIa trial of autologous tumor vaccine and temozolomide administration in patients with primary glioblastoma |
| Date of disclosure of the study information | 2008/11/01 |
| Last modified on | 2018/03/26 09:55:18 |
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Basic information
Public title
Phase I/IIa trial of autologous tumor vaccine and temozolomide administration in patients with primary glioblastoma
Acronym
Autologous tumor vaccine and temozolomide for glioblastoma
Scientific Title
Phase I/IIa trial of autologous tumor vaccine and temozolomide administration in patients with primary glioblastoma
Scientific Title:Acronym
Autologous tumor vaccine and temozolomide 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 vaccine 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
Tumor-regression rate, disease-control rate
QOL
Neurological improvement
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.
6) Informed consent is obtained from each patient
7) Vaccination and follow-up of each patient is possible to perform within the institutions of this study.
8) Lymphocyte count in peripheral blood is 1000/mm3 or more.
Key exclusion criteria
1) Patients who have been administered or are taking corticosteroid or anticancer drugs.
2) Patients with high intracranical pressure.
3) Patients with severe myelosupression.
4) Patients with severe complication including hematopathy
5) Patients with malignant tumor or cancer.
6) Pregnant or nursing woman, or woman willing to be pregnant.
7) Patients participate in other study during or within 6 months before temozolomide administration in this study.
8) Other reasons for exclusion
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Ishikawa |
Organization
University of Tsukuba
Division name
Department of Neurosurgery, Neurological Institute
Zip code
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki
TEL
029-853-3220
e-ishikawa@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichi Ishikawa |
Organization
University of Tsukuba
Division name
Department of Neurosurgery, Doctoral Program in Functional and Regulatory Medical Science, Graduate
Zip code
Address
Tennodai 1-1-1, Tsukuba, Ibaraki, Japan
TEL
029-853-3220
Homepage URL
e-ishikawa@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Cell Medicine Cooperation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Womens Medical 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
筑波大学附属病院（茨城県）、東京女子医科大学附属病院（東京都）、大分大学附属病院（大分県）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | 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
This treatment regimen was well tolerated by all patients. The percentage of patients with progression-free survival (PFS)>=24 months was 33%. The median PFS, median overall survival (OS), and the actuarial 2- and 3-year survival rates of the 24 patients were 8.2 months, 22.2 months, 47%, and 38%, respectively.
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
| 2008 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 01 | Day |
Other
Other related information
The median PFS in patients with a delayed-type hypersensitivity (DTH) response after the third AFTV injection (DTH-2) of 10 mm or larger surpassed the median length of follow-up for progression-free patients (29.5 months), which was significantly greater than the median PFS in patients with a smaller DTH-2 response.
Management information
Registered date
| 2008 | Year | 10 | Month | 10 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001734
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