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

GC Cell

Status and phase: Completed; Phase 3

Conditions: Glioblastoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00807027

IcmLCBT_301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Control Group

No Intervention group

Description:

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.

Test Group

Experimental group

Description:

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).

Treatment:

Drug: Activated T lymphocyte(Immuncell-LC)