Unique ID issued by UMIN | UMIN000006849 |
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Receipt number | R000007515 |
Scientific Title | Dendritic cell-based immunotherapy against metastatic melanoma patients |
Date of disclosure of the study information | 2012/01/01 |
Last modified on | 2011/12/06 19:25:49 |
Dendritic cell-based immunotherapy against metastatic melanoma patients
Dendritic cell-based immunotherapy
Dendritic cell-based immunotherapy against metastatic melanoma patients
Dendritic cell-based immunotherapy
Japan |
metastatic melanoma
Hematology and clinical oncology | Dermatology |
Malignancy
NO
Evaluation for safety and efficacy of dendritic cell-based immunotherapy
Efficacy
Exploratory
Pragmatic
Phase II
Antitumor effect and safety of DC-based immunotherapy
Immunological effect, effect on overall survival time
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Vaccine |
Administration of peptide cocktail and KLH-treated dendritic cell vaccines to malignant melanoma patients within the dose of 5x107
20 | years-old | <= |
80 | years-old | > |
Male and Female
1. Histological diagnosis of malignant melanoma
2. Metastatic melanoma of clinical stage IV
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. Tolerable to apheresis procedure
9. No severe hematostatic dysfunction
10. Informed consents obtained from patients
11. Survival for more than 6 months expected
12. 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. Pregnant women
5. Hypersensitivity to DC vaccine
6. Severe immunological disoedres (autoimmune disease, immunosuppression)
7. Multiple cancers
8. Anaphylaxis to synthetic peptides
24
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
1st name | |
Middle name | |
Last name | Yasuto Akiyama, M.D. |
Shizuoka Cancer Center Research Institute
Immunotherapy Division
1007 Shimonagakubo, Nagaizumi-cho, Snto-gun, Shizuoka 411-8777
055-989-5222
Shizuoka Cancer Center
Shizuoka Prefecture
Self funding
NO
2012 | Year | 01 | Month | 01 | Day |
Unpublished
Completed
2004 | Year | 02 | Month | 09 | Day |
2004 | Year | 04 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 12 | Month | 06 | Day |
2011 | Year | 12 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007515
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