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Japanese Journal of Clinical Oncology 2008 38(10):715-718; doi:10.1093/jjco/hyn095
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© The Author (2008). Published by Oxford University Press. All rights reserved

A Multicenter Phase I Trial of Interferon-β and Temozolomide Combination Therapy for High-grade Gliomas (INTEGRA Study)

Toshihiko Wakabayashi1, Takamasa Kayama2, Ryo Nishikawa3, Hiroshi Takahashi4, Toshiki Yoshimine5, Nobuo Hashimoto6, Tomokazu Aoki7, Kaoru Kurisu8, Atsushi Natsume1, Masatoshi Ogura1 and Jun Yoshida1

1 Department of Neurosurgery, Nagoya University School of Medicine, Nagoya
2 Department of Neurosurgery, Yamagata University School of Medicine, Yamagata
3 Department of Neurosurgery, Saitama Medical University, Saitama
4 Department of Neurosurgery, Nippon Medical School, Tokyo
5 Department of Neurosurgery, Osaka University School of Medicine, Osaka
6 Department of Neurosurgery, Kyoto University School of Medicine, Kyoto
7 Department of Neurosurgery, Kitano Hospital, Osaka
8 Department of Neurosurgery, Hiroshima University School of Medicine, Hiroshima, Japan

For reprints and all correspondence: Toshihiko Wakabayashi, Department of Neurosurgery, Nagoya University School of Medicine, Nagoya, Japan. E-mail: wakabat{at}med.nagoya-u.ac.jp

Received June 24, 2008; accepted August 14, 2008

A multicenter phase I clinical trial, namely, Integrated Japanese Multicenter Clinical Trial: A Phase I Study of Interferon-β and Temozolomide for Glioma in Combination with Radiotherapy (INTEGRA Study), is being conducted for patients with high-grade glioma in order to evaluate the safety, feasibility and preliminary clinical effectiveness of the combination of interferon-β and temozolomide. The primary endpoint is incidence of adverse events. The secondary endpoints are progression-free survival time and overall survival time. In addition, objective tumor response will be evaluated in a subpopulation of patients with the measurable disease. The reduction rate of tumor will be calculated according to Response Evaluation Criteria In Solid Tumors for measurable tumors as determined by magnetic resonance imaging. Subsequently, the overall response will be evaluated based on the results of measurable and non-measurable tumors. Ten newly diagnosed and 10 recurrent patients will be enrolled in this study.

Key Words: chemo-phase I-II-III • clinical trials • CNS


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