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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


Phase 3
18 Years
70 Years
Not Enrolling
Both
Glioblastoma

Thank you

Trial Information

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


Compare clinical efficacy of group treated with cell theraputic INNOCELL
Immuncell-LC evaluated by progression free survival with that of untreated group.

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MRI

Outcome Time Frame:

Every 3months from the screening

Safety Issue:

Yes

Principal Investigator

Chunghyun Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hanyang University

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

IcmLCBT_301

NCT ID:

NCT00807027

Start Date:

December 2008

Completion Date:

October 2012

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • Newly diagnosed Glioblastoma
  • Glioblastoma

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