Unique ID issued by UMIN | UMIN000011859 |
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Receipt number | R000013862 |
Scientific Title | A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer |
Date of disclosure of the study information | 2013/10/01 |
Last modified on | 2018/10/07 11:51:35 |
A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer
WT1Ov
A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer
WT1Ov
Japan |
Ovarian cancer
Obstetrics and Gynecology |
Malignancy
NO
To investigate the efficacy of WT1 peptide-based cancer vaccine as the maitenance tharapy following surgical and chemotherapy for the patients with advanced-stage ovarian cancer
Efficacy
Exploratory
Phase II
2-year disease free survival rate
overall survival, antigen-specific immunity, safety, and so on
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
WT1 peptide-based cancer vaccine is contained 3 kinds of WT1 peptides (np 126: 2.0mg, mp235: 2.0mg, and np332: 2.0mg) and Montanide ISA51 adjuvant.
Intradermally injection of WT1 vaccine will be continued for 1 year, in total 17 times vaccinations will be done.
from day1 to day85: biweekly (in total 7 times)
from 86 to day365: monthly (in total 10 times)
If a patinet request to receive WT1 vaccine continuously afer completion, WT1 vaccine may be administrated at 8-weeks interval for 1 year.
20 | years-old | <= |
79 | years-old | >= |
Female
1) Pathologically confirmed ovarian cancer
2) FIGO stage III or IV
3) Received Taxane + Platinum based chemotherapy as neo-adjuvant and/or Adjuvant chemotherapy
4) Complete remission confirmed with radiological evaluations
5) From 28 to 55 days after completion of surgical + chemotherapy
6) ECOG-PS: 0 - 1
7) Age: 20 - 79 years old
8) HLA-A*24:02 and / or HLA-A*02:01
9) no previous history of treatment for other cancers within at least 5 years
10) adequate organ functions
Neutrophils > 1,200
Platelets > 75, 000
Hb > 8.5
sCr < 2.0mg/dl
T-Bil < 2.0mg/dl
AST / ALT < 100 IU/L
11) Informed consent
1) Residual diseases after surgical and chemotherapy
2) Received intra-peritoneum chemotherapy
3) Active other cancers except for carcinoma in situ treated completely
4) Received Immunosuppresive agents actively at registration
5) Received Growth factor, including G-CSF, Epo, TPO, within 14 days before registration
6) Received other tested agents within 28 days before registration
7) Received WT1 vaccine
8) Past history of Myeloproliferative diseases, MSD
9) Past history of pulmonary fibrosis, interstitial pneumonitis
10) Past history of autoimmune diseases, including collagen diseases
11) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on
12) active infectious diseases
13) Past history of HIV, HBV, and HCV infections
14) Grade 3 or severer Neutopatic complications
15) Hypersensitivity to some drugs
16) Pregnancy / lactation
17) Severe Psychological Problems
18) Other severe problems unsuitable for this study
55
1st name | |
Middle name | |
Last name | Haruo Sugiyama |
Osaka university graduate school of medicine
Functional diagnostic science
2-2, Yamada-oka, Suita-city, Osaka, Japan
06-6879-2593
sugiyama@sahs.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Sumiyuki Nishida |
Osaka university graduate school of medicine
Cancer Immunotherapy
2-2, Yamada-oka, Suita-city, Osaka, Japan
06-6879-3676
clinical-trial@cit.med.osaka-u.ac.jp
Osaka university graduate school of medicine
the Japanese Ministries of Education, Culture, Sports, Science and Technology
NO
2013 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 18 | Day |
2013 | Year | 10 | Month | 08 | Day |
2013 | Year | 09 | Month | 25 | Day |
2018 | Year | 10 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013862
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