A multicenter phase I trial of Interferon-β and Temozolomide Combination therapy for high-grade gliomas (INTEGRA Study)

被引：15

作者：

Wakabayashi, Toshihiko ^{[1
]}

Kayama, Takamasa ^{[2
]}

Nishikawa, Ryo ^{[3
]}

Takahashi, Hiroshi ^{[4
]}

Yoshimine, Toshiki ^{[5
]}

Hashimoto, Nobuo ^{[6
]}

Aoki, Tomokazu ^{[7
]}

Kurisu, Kaoru ^{[8
]}

Natsume, Atsushi ^{[1
]}

Ogura, Masatoshi ^{[1
]}

Yoshida, Jun ^{[1
]}

机构：

[1] Nagoya Univ, Sch Med, Dept Neurosurg, Nagoya, Aichi 466, Japan

[2] Yamagata Univ, Sch Med, Dept Neurosurg, Yamagata 99023, Japan

[3] Saitama Med Univ, Dept Neurosurg, Saitama, Japan

[4] Nippon Med Sch, Dept Neurosurg, Tokyo 113, Japan

[5] Osaka Univ, Sch Med, Dept Neurosurg, Osaka, Japan

[6] Kyoto Univ, Sch Med, Dept Neurosurg, Kyoto 606, Japan

[7] Kitano Hosp, Dept Neurosurg, Osaka, Japan

[8] Hiroshima Univ, Sch Med, Dept Neurosurg, Hiroshima, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2008年 / 38卷 / 10期

关键词：

chemo-phase I-II-III; clinical trials; CNS;

D O I：

10.1093/jjco/hyn095

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

A multicenter phase I clinical trial, namely, Integrated Japanese Multicenter Clinical Trial: A Phase I Study of Interferon-beta 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-beta 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.

引用

页码：715 / 718

页数：4

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