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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00807027
Recruitment Status : Completed
First Posted : December 11, 2008
Last Update Posted : October 25, 2012
Sponsor:
Information provided by (Responsible Party):
Green Cross Cell Corporation

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 11, 2008
Last Update Posted Date October 25, 2012
Study Start Date  ICMJE December 2008
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
MRI [ Time Frame: Every 3months from the screening ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) [ Time Frame: Every 3months from the screening ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE 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)

Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 10, 2008)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807027
Other Study ID Numbers  ICMJE IcmLCBT_301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Green Cross Cell Corporation
Study Sponsor  ICMJE Green Cross Cell Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chunghyun Kim, MD Hanyang University
PRS Account Green Cross Cell Corporation
Verification Date October 2012

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