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

COMPLETEDPHASE3

Clinical Trial to Assess the Efficacy and Safety of '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

NCT00807027•GC Cell Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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

Locations (7)

Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Gyunghee University Medical Center

Seoul, South Korea

Konkuk University

Seoul, South Korea

Korea University Anam Hospital

Seoul, South Korea

Samsung Seoul Medical Center

Seoul, South Korea

Seoul Asan Medical Center

Seoul, South Korea

Yeonsei University Medical Center

Seoul, South Korea

Key Dates

Start Date

December 5, 2008

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

October 10, 2025

Enrollment

180

ACTUAL participants

Conditions

Glioblastoma

Interventions

Activated T lymphocyte(Immuncell-LC)

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Targeted Pediatric High-Grade Glioma Therapy

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma