A multicenter phase I trial of interferon-beta and temozolomide combination therapy for high-grade gliomas (INTEGRA Study).
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.
Wakabayashi
Toshihiko
T
Department of Neurosurgery, Nagoya University School of Medicine, Nagoya, Japan. wakabat@med.nagoya-u.ac.jp
Kayama
Takamasa
T
Nishikawa
Ryo
R
Takahashi
Hiroshi
H
Yoshimine
Toshiki
T
Hashimoto
Nobuo
N
Aoki
Tomokazu
T
Kurisu
Kaoru
K
Natsume
Atsushi
A
Ogura
Masatoshi
M
Yoshida
Jun
J
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D005910:Glioma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D016899:Interferon-beta / Q000008:administration & dosage; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D000077204:Temozolomide; D016896:Treatment Outcome
D016899:Interferon-beta; D003606:Dacarbazine; D000077204:Temozolomide