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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation
ClinicalTrials.gov Identifier:
NCT00807027
First received: December 10, 2008
Last updated: October 24, 2012
Last verified: October 2012

December 10, 2008
October 24, 2012
December 2008
October 2012   (final data collection date for primary outcome measure)
MRI [ Time Frame: Every 3months from the screening ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00807027 on ClinicalTrials.gov Archive Site
Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) [ Time Frame: Every 3months from the screening ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
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

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.

<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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma
Drug: 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)

  • No Intervention: 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.
  • Experimental: Test 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).
    Intervention: Drug: Activated T lymphocyte(Immuncell-LC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00807027
IcmLCBT_301
No
Green Cross Cell Corporation
Green Cross Cell Corporation
Not Provided
Principal Investigator: Chunghyun Kim, MD Hanyang University
Green Cross Cell Corporation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP