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
  Purpose

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.


Condition Intervention Phase
Glioblastoma
Drug: Activated T lymphocyte(Immuncell-LC)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Green Cross Cell Corporation:

Primary Outcome Measures:
  • MRI [ Time Frame: Every 3months from the screening ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS) [ Time Frame: Every 3months from the screening ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: December 2008
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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)


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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807027

Locations
Korea, Republic of
Hanyang University Guri Hospital
Guri, Gyeonggi-Do, Korea, Republic of
Konkuk University
Seoul, Korea, Republic of
Gyunghee University Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Yeonsei University Medical Center
Seoul, Korea, Republic of
Samsung Seoul Medical Center
Seoul, Korea, Republic of
Seoul Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Green Cross Cell Corporation
Investigators
Principal Investigator: Chunghyun Kim, MD Hanyang University
  More Information

No publications provided

Responsible Party: Green Cross Cell Corporation
ClinicalTrials.gov Identifier: NCT00807027     History of Changes
Other Study ID Numbers: IcmLCBT_301
Study First Received: December 10, 2008
Last Updated: October 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Green Cross Cell Corporation:
Glioblastoma
Newly diagnosed Glioblastoma

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014