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

<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.

• Activated T lymphocyte(Immuncell-LC) (Drug): 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)

Primary outcomes

• 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 outcomes

• 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.]

Sex: All, ages: 18 Years to 70 Years

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

Participant flow

Outcome results

• Progression-free Survival(PFS) (Primary), Median, months: Control Group 5.4 (3.3 to 7.9); CIK Immunotherapy Group 8.1 (5.8 to 8.5)
• Overall Survival(OS) (Secondary), Median, months: Control Group 16.88 (13.91 to 21.94); CIK Immunotherapy Group 22.47 (17.20 to 23.85)

Adverse events

Serious adverse events by term

9 more terms not shown.

Other adverse events by term

293 more terms not shown.

• Chunghyun Kim, MD, Principal investigator, Hanyang University