Spots Global Cancer Trial Database for Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
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Trial Identification
Brief Title: Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Official Title: Multi-center, Randomized, Open-label Phase 3 Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Study ID: NCT00807027
Conditions
Interventions
Study Description
Brief Summary: This clinical study was planned in order to assess the superiority of INNOCELL Corp. "Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Temozolomide to glioblastoma patients when compared with the control group who did not receive administration of the drug.
Detailed Description: \<Primary Purpose\> Compare clinical efficacy of group treated with cell theraputic INNOCELL Immuncell-LC evaluated by progression free survival with that of untreated group. \<Secondary Purpose\> Compare clinical efficacy of group treated with INNOCELL Immuncell-LC, a drug for treating glioblastoma evaluated by overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) and that of untreated group, and evaluate adverse reactions, clinical pathological tests, and its safety.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hanyang University Guri Hospital, Guri, Gyeonggi-Do, Korea, Republic of
Gyunghee University Medical Center, Seoul, , Korea, Republic of
Konkuk University, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Samsung Seoul Medical Center, Seoul, , Korea, Republic of
Seoul Asan Medical Center, Seoul, , Korea, Republic of
Yeonsei University Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Chunghyun Kim, MD
Affiliation: Hanyang University
Role: PRINCIPAL_INVESTIGATOR
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