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A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer

Phase 2
Conditions
Ovarian cancer
Registration Number
JPRN-UMIN000011859
Lead Sponsor
Osaka university graduate school of medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
55
Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2-year disease free survival rate
Secondary Outcome Measures
NameTimeMethod
overall survival, antigen-specific immunity, safety, and so on
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