Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea

Study Overview
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Brief Summary
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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
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<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.

Official Title
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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

Conditions
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Glioblastoma

Intervention / Treatment
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* Drug: Activated T lymphocyte(Immuncell-LC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks. | |
| Experimental: Test Group<br>The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times). | Drug: Activated T lymphocyte(Immuncell-LC)<br>* Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109 2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI |  | Every 3months from the screening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) |  | Every 3months from the screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glioblastoma, Newly diagnosed Glioblastoma