Unique ID issued by UMIN | UMIN000000914 |
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Receipt number | R000001099 |
Scientific Title | Dendritic cell-based tumor-specific immunotherapy against malignant brain tumor - Phase I clinical trial |
Date of disclosure of the study information | 2009/12/01 |
Last modified on | 2013/01/09 11:26:12 |
Dendritic cell-based tumor-specific immunotherapy against malignant brain tumor - Phase I clinical trial
Immunotherapy against malignant brain tumor
Dendritic cell-based tumor-specific immunotherapy against malignant brain tumor - Phase I clinical trial
Immunotherapy against malignant brain tumor
Japan |
Malignant brain tumor (malignant glioma)
Hematology and clinical oncology | Neurology | Neurosurgery |
Malignancy
YES
Evaluation for a safety of activated dendritic cell-based immunotherapy
Safety
Exploratory
Pragmatic
Phase I
Safety of immunotherapy
Antitumor effect, Immunological effect
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine |
Administration of multiple peptides-treated activated dendritic cell vaccines to malignant glioma patients in a dose-escalation manner
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Histological diagnosis of malignant
glioma
2. Poor response to standard treatment
(SD or PD)
3. 20 <= Age <80
4. Performance status; 0-2
5. Measurable lesions in imaging
diagnosis
6. HLA genotyping ; HLA-A2 or A24
7. No severe organ dysfunction
8. No severe hematostatic dysfunction
9. Informed consents obtained from
patients
10. Survival for more than 6 months
expected
11. More than 4 weeks interval after
last treatment against cancer
1. Within 28 days after the last
treatment against cancer
2. Severe systemic infection,
hematostatic dysfunction, and organ
disorder
3. Steroid treatment, except used for
cerebral decompression
4. Hypersensitivity to DC vaccine
5. Severe immunological disorders
(autoimmune disease, immunosuppression)
6. Multiple cancers
7. Anaphylaxis to synthetic peptides
12
1st name | |
Middle name | |
Last name | Yasuto Akiyama, M.D. |
Shizuoka Cancer Center Research Institute
Immunotherapy Division
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777
055-989-5222
1st name | |
Middle name | |
Last name | Yasuto Akiyama, M.D. |
Shizuoka Cancer Center Research Institute
Immunotherapy Division
y.akiyama@scchr.jp
Shizuoka Cancer Center
Shizuoka Prefecture
Self funding
NO
2009 | Year | 12 | Month | 01 | Day |
Published
Completed
2007 | Year | 04 | Month | 20 | Day |
2007 | Year | 09 | Month | 01 | Day |
2012 | Year | 10 | Month | 01 | Day |
2007 | Year | 11 | Month | 30 | Day |
2013 | Year | 01 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001099
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