Status:
COMPLETED
Clinical Trial to Assess the Efficacy and Safety of 'Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Lead Sponsor:
GC Cell Corporation
Conditions:
Glioblastoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 pa...
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\> Co...
Eligibility Criteria
Inclusion
- Patients who, prior to the study, received explanation of the purpose and content of study and of characteristics of the test drug from the test administrator and have consented to the study by providing signature of self, guardian, or legal representative.
- Patients who are between 18 and 70 years of age
- Patients whose cause of cancer has been found to be glioblastoma via pathological testing
- patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study
- Patients whose survival is expected to be longer than 3 months
- Patients whose KPS is greater than 60
- Patients who satisfy the following conditions of the blood test, kidney function test, and liver function test
- Hemoglobin is bigger than 10 gm%
- Platelet Count is bigger than 100,000/µL
- Absolute granulocyte count is bigger than 1,500/µL
- BUN or Creatinine 1.5 x upper normal limit
- Bilirubin level is smaller than 2.0 mg/dL
- SGOT, SGPT, alkaline phosphatase is smaller than 1.5 x upper normal limit
Exclusion
- Patients who have been determined to have serious Cardio - Pulmonary function disability by the clinical study staff
- Patients who are immune deficient or have a history of auto immune diseases (Ex. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
- Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of skin cancer, local prostate cancer, and cervical cancer.
- Patients with history of severe allergies
- Patients with serious mental illness
- Patients who are pregnant or nursing
- Patients who have participated in other clinical tests in the recent 4 weeks prior to the study
Key Trial Info
Start Date :
December 5 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00807027
Start Date
December 5 2008
End Date
October 1 2012
Last Update
October 10 2025
Active Locations (7)
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1
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
2
Gyunghee University Medical Center
Seoul, South Korea
3
Konkuk University
Seoul, South Korea
4
Korea University Anam Hospital
Seoul, South Korea