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

NCT00807027 | Completed Phase 3 Results

• 1 other identifier: IcmLCBT_301
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 7

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.

Conditions

Glioblastoma

Keywords

Glioblastoma; Newly diagnosed Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival(PFS)

  Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3\~12 months thereafter during the follow-up phase.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.

Secondary Outcomes (1)

• Overall Survival(OS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.

Study Arms (2)

Control Group

NO INTERVENTION

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

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)

Interventions

Activated T lymphocyte(Immuncell-LC) DRUG

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)

Test Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are between 18 and 70 years of age
• Patients whose cause of cancer has been found to be glioblastoma via pathological testing
• patients who have received surgery for glioblastoma (Complete or partial extirpation or biopsy) 2 weeks prior to the study
• Patients whose survival is expected to be longer than 3 months
• Patients whose KPS is greater than 60
• 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

You may not qualify if:

• Patients who have been determined to have serious Cardio - Pulmonary function disability by the clinical study staff
• 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.)
• 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.
• Patients with history of severe allergies
• Patients with serious mental illness
• Patients who are pregnant or nursing
• Patients who have participated in other clinical tests in the recent 4 weeks prior to the study

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (7)

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Location

Gyunghee University Medical Center

Seoul, South Korea

Location

Konkuk University

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Samsung Seoul Medical Center

Seoul, South Korea

Location

Seoul Asan Medical Center

Seoul, South Korea

Location

Yeonsei University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: CRA of Clinical Trial
• Organization: GREEN CROSS CELL

a1pole@greencrosscell.com

82-2-2101-0665

Study Officials

• Chunghyun Kim, MD

  Hanyang University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: December 5, 2008
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 10, 2025
• Results First Posted: October 10, 2025

Record last verified: 2025-09

Locations

KR (7)