PMID- 20032435 OWN - NLM STAT- MEDLINE DCOM- 20100126 LR - 20111117 IS - 1791-7530 (Electronic) IS - 0250-7005 (Linking) VI - 29 IP - 11 DP - 2009 Nov TI - Wilms' tumor 1 (WT1) peptide immunotherapy for gynecological malignancy. PG - 4779-84 AB - BACKGROUND: The object of this study was to investigate the safety and clinical response of immunotherapy targeting the WT1 (Wilms' tumor 1) gene product in patients with gynecological cancer. PATIENTS AND METHODS: Twelve patients with WT1/human leukocyte antigen (HLA)-A*2402-positive gynecological cancer were included in a Phase II clinical trial of WT1 vaccine therapy. In all the patients, the tumors were resistant to standard therapy. The patients received intradermal injections of a HLA-A*2402-restricted, modified 9-mer WT1 peptide every week for 12 weeks. Tumor size, which was measured by computed tomography (CT), was determined every 4 weeks. The responses were analyzed according to Response Evaluation Criteria in Solid Tumors (RECIST). RESULTS: The protocol was well tolerated; only local erythema occurred at the WT1 vaccine injection site. The clinical responses were as follows: stable disease (SD) in 3 patients and progressive disease (PD) in 9 patients. No patients had a complete (CR) or partial response (PR). The disease control rate was 25.0%. CONCLUSION: Although a small, uncontrolled, nonrandomized trial, this study showed that WT1 vaccine therapy for patients with gynecological cancer was safe and produced a clinical response. FAU - Ohno, Satoshi AU - Ohno S AD - International Research and Educational Institute for Integrated Medical Sciences, Tokyo Women's Medical University, Tokyo, 162-8666, Japan. satoshi.ohno55@gmail.com FAU - Kyo, Satoru AU - Kyo S FAU - Myojo, Subaru AU - Myojo S FAU - Dohi, Satoshi AU - Dohi S FAU - Ishizaki, Junko AU - Ishizaki J FAU - Miyamoto, Ken-Ichi AU - Miyamoto K FAU - Morita, Satoshi AU - Morita S FAU - Sakamoto, Jun-Ichi AU - Sakamoto J FAU - Enomoto, Takayuki AU - Enomoto T FAU - Kimura, Tadashi AU - Kimura T FAU - Oka, Yoshihiro AU - Oka Y FAU - Tsuboi, Akihiro AU - Tsuboi A FAU - Sugiyama, Haruo AU - Sugiyama H FAU - Inoue, Masaki AU - Inoue M LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - Greece TA - Anticancer Res JT - Anticancer research JID - 8102988 RN - 0 (Cancer Vaccines) RN - 0 (HLA-A Antigens) RN - 0 (HLA-A*24:02 antigen) RN - 0 (HLA-A24 Antigen) RN - 0 (Peptide Fragments) RN - 0 (WT1 Proteins) SB - IM MH - Adult MH - Aged MH - Cancer Vaccines/*therapeutic use MH - Female MH - Genital Neoplasms, Female/immunology/*therapy MH - HLA-A Antigens/biosynthesis/immunology MH - HLA-A24 Antigen MH - Humans MH - Injections, Intradermal MH - Middle Aged MH - Peptide Fragments/administration & dosage/immunology MH - WT1 Proteins/*immunology EDAT- 2009/12/25 06:00 MHDA- 2010/01/27 06:00 CRDT- 2009/12/25 06:00 PHST- 2009/12/25 06:00 [entrez] PHST- 2009/12/25 06:00 [pubmed] PHST- 2010/01/27 06:00 [medline] AID - 29/11/4779 [pii] PST - ppublish SO - Anticancer Res. 2009 Nov;29(11):4779-84.