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Japanese Journal of Clinical Oncology Advance Access originally published online on April 12, 2006
Japanese Journal of Clinical Oncology 2006 36(4):231-236; doi:10.1093/jjco/hyl005
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© 2006 Foundation for Promotion of Cancer Research

A Phase I/II Trial of a WT1 (Wilms' Tumor Gene) Peptide Vaccine in Patients with Solid Malignancy: Safety Assessment Based on the Phase I Data

Satoshi Morita1, Yoshihiro Oka2, Akihiro Tsuboi3, Manabu Kawakami3, Motohiko Maruno4, Shuichi Izumoto4, Tadashi Osaki2, Tetsuya Taguchi5, Takafumi Ueda6, Akira Myoui6, Sumiyuki Nishida3, Toshiaki Shirakata2, Satoshi Ohno7, Yusuke Oji7, Katsuyuki Aozasa8, Jun Hatazawa9, Keiko Udaka10, Hideki Yoshikawa6, Toshiki Yoshimine4, Shinzaburo Noguchi5, Ichiro Kawase2, Shin-ichi Nakatsuka11, Haruo Sugiyama7 and Junichi Sakamoto12

1 Department of Epidemiology and Health Care Research, Kyoto University Graduate School of Medicine, Kyoto, Departments of 2 Molecular Medicine, 3 Cancer Immunotherapy, 4 Neurosurgery, 5 Surgical Oncology, 6 Orthopaedics, 7 Functional Diagnostic Science, 8 Pathology, 9 Nuclear Medicine and Tracer Kinetics, Osaka University Graduate School of Medicine, Suita, Osaka, 10 Department of Immunology, Kochi Medical School, Nankoku, Kochi, 11 Department of Laboratory Medicine, National Hospital Organization, Osaka Minami Medical Center, Kawachinagano, Osaka and 12 Department of Epidemiological & Clinical Research Information Management, Kyoto University Graduate School of Medicine, Kyoto, Japan

For reprints and all correspondence: Satoshi Morita, PhD, Department of Epidemiology and Health care Research, Kyoto University Graduate School of Medicine, Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. E-mail: satoshi_morita{at}pbh.med.kyoto-u.ac.jp

Received September 7, 2005; accepted January 5, 2006

Objective: We conducted a phase I study to investigate the safety of a weekly WT1 tumor vaccine therapy in patients with solid tumors that had been refractory to all other anti-cancer therapies.

Methods: Skin-test-negative patients were intradermally injected weekly for 12 weeks with 3.0 mg of an HLA-A*2402-restricted modified 9-mer WT1 peptide emulsified in Montanide ISA51 adjuvant. We estimated the Bayesian posterior probability of the occurrence of grade 3 or 4 toxicity when receiving the weekly WT1 vaccination. This analysis provided the basis for making a decision to terminate the phase I study and switch to phase II. Moreover, we performed an exploratory assessment of the anti-tumor effects of WT1 treatment.

Results: Ten patients received 114 vaccinations with WT1 on a weekly schedule. No grade 3 or 4 toxicities were observed. Based on the Bayesian approach, it was highly likely that the probability of grade 3 or 4 toxicity was below 20% (the posterior probability = 0.914). Fifteen grade 2 and two grade 1 toxicities were observed; all of these incidents, however, were determined by the Independent Data and Safety Monitoring Committee to be unrelated to the WT1 treatment. One patient exhibited a partial response; five additional patients had stable disease while receiving weekly WT1 treatment.

Conclusion: This paper confirms that the potential toxicities of the treatment schedule of weekly WT1 vaccination are acceptable and suggested a potential anti-tumor effect. Consequently, we validated the decision to continue to the phase II trial.

Key Words: WT1 peptide vaccine • solid tumor • phase I trial • Bayesian approach • weekly schedule


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