Glioblastoma
Conditions
Keywords
Glioblastoma, Newly diagnosed Glioblastoma
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.
Interventions
DRUGActivated T lymphocyte(Immuncell-LC)
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)
Sponsors
GC Cell Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Patients who are between 18 and 70 years of age 3. Patients whose cause of cancer has been found to be glioblastoma via pathological testing 4. patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study 5. Patients whose survival is expected to be longer than 3 months 6. Patients whose KPS is greater than 60 7. 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
1. Patients who have been determined to have serious Cardio - Pulmonary function disability by the clinical study staff 2. 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.) 3. 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. 4. Patients with history of severe allergies 5. Patients with serious mental illness 6. Patients who are pregnant or nursing 7. Patients who have participated in other clinical tests in the recent 4 weeks prior to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival(PFS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months. | Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3\ 12 months thereafter during the follow-up phase. |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group 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. | 89 |
| CIK Immunotherapy Group 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).
Activated T lymphocyte(Immuncell-LC): 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) | 91 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 14 |
Baseline characteristics
| Characteristic | CIK Immunotherapy Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 55.0 years | 54.0 years | 54.5 years |
| Global health status/Quality of life | 58 units on a scale | 50 units on a scale | 54 units on a scale |
| Karnofsky performance scale | 90.0 units on a scale | 90 units on a scale | 90.0 units on a scale |
| Region of Enrollment South Korea | 91 participants | 89 participants | 180 participants |
| Sex: Female, Male Female | 40 Participants | 38 Participants | 78 Participants |
| Sex: Female, Male Male | 51 Participants | 51 Participants | 102 Participants |
| Tumor size | 4.2 centimeter | 1.4 centimeter | 2.8 centimeter |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 52 / 89 | 51 / 91 |
| other Total, other adverse events | 83 / 89 | 84 / 91 |
| serious Total, serious adverse events | 31 / 89 | 35 / 91 |
Outcome results
Primary
Progression-free Survival(PFS)
Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3\ 12 months thereafter during the follow-up phase.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Progression-free Survival(PFS) | 5.4 months |
| CIK Immunotherapy Group | Progression-free Survival(PFS) | 8.1 months |
Secondary
Overall Survival(OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Overall Survival(OS) | 16.88 months |
| CIK Immunotherapy Group | Overall Survival(OS) | 22.47 months |