Unique ID issued by UMIN | UMIN000000976 |
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Receipt number | R000001158 |
Scientific Title | Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Oral Cancer |
Date of disclosure of the study information | 2008/01/10 |
Last modified on | 2008/01/09 09:54:12 |
Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Oral Cancer
Phase I Clinical Study of Survivin-2B Peptide Vaccine Therapy
Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Oral Cancer
Phase I Clinical Study of Survivin-2B Peptide Vaccine Therapy
Japan |
Advanced or recurrent oral cancer
Oral surgery |
Malignancy
NO
Evaluation of the safety and efficacy of survivin-2B peptide vaccine therapy in patients with oral cancer.
Safety,Efficacy
Pragmatic
Phase I
Toxicity
Clinical and immunological responses. Clinical responses are evaluated by RECIST criteria and change of tumor marker levels. Immunological responses are evaluated by DTH, tetramer staining and ELISPOT assay.
Interventional
Parallel
Non-randomized
Open -no one is blinded
Uncontrolled
2
Treatment
Maneuver |
Survivin-2B peptide vaccination at a dose of 0.1mg every 2 weeks.
Survivin-2B peptide vaccination at a dose of 1.0mg every 2 weeks.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
1) Histologically proven oral cancer, 2) HLA class I-positive and survivin-positive in the cancerous lesions by immunohistochemistry, 3) HLA-A*2402 positive, 4) unresectable advanced or recurrent oral cancer, 5) from 20-85 years old, 6) ECOG performance status between 0 and 3.
1) prior cancer therapy, such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, 2) presence of other cancers that might influence the prognosis, 3) immunodeficiency or a history of splenectomy, 4) severe cadiac insufficiency, acute infection, or hematopoietic failure, 5) ongoing brest-feeding, 6) unsuitability for the trial based on clinical judgement.
10
1st name | |
Middle name | |
Last name | Akihiro Miyazaki |
Sapporo Medical University
Department of Oral Surgery
South-1, West-16, Chuo-ku, Sapporo, Japan
011-611-2111(ext.3578)
1st name | |
Middle name | |
Last name | Akihiro Miyazaki |
Sapporo Medical University
Department of Oral Surgery
South-1, West-16, Chuo-ku, Sapporo, Japan
011-611-2111(ext.3578)
amiyazak@sapmed.ac.jp
Department of Oral Surgery, Sapporo Medical University School of Medicine
Japan Science and Technology Corporation Innovation Plaza Hokkaido, Sapporo , Japan
Japan
Department of Pathology, Sapporo Medical University School of Medicine
NO
2008 | Year | 01 | Month | 10 | Day |
Partially published
No longer recruiting
2003 | Year | 09 | Month | 10 | Day |
2003 | Year | 09 | Month | 01 | Day |
2006 | Year | 07 | Month | 01 | Day |
2008 | Year | 01 | Month | 09 | Day |
2008 | Year | 01 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001158
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