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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00807027
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 GC Cell Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Chunghyun Kim, MD
Principal Investigator Affiliation Hanyang University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Additional Details

Compare clinical efficacy of group treated with cell theraputic INNOCELL Immuncell-LC evaluated by progression free survival with that of untreated group. 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.

Arms & Interventions

Arms

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).

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hanyang University Guri Hospital, Guri, Gyeonggi-Do, Korea, Republic of

Status

Address

Hanyang University Guri Hospital

Guri, Gyeonggi-Do,

Gyunghee University Medical Center, Seoul, Korea, Republic of

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Gyunghee University Medical Center

Seoul, ,

Konkuk University, Seoul, Korea, Republic of

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Konkuk University

Seoul, ,

Korea University Anam Hospital, Seoul, Korea, Republic of

Status

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Korea University Anam Hospital

Seoul, ,

Samsung Seoul Medical Center, Seoul, Korea, Republic of

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Samsung Seoul Medical Center

Seoul, ,

Seoul Asan Medical Center, Seoul, Korea, Republic of

Status

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Seoul Asan Medical Center

Seoul, ,

Yeonsei University Medical Center, Seoul, Korea, Republic of

Status

Address

Yeonsei University Medical Center

Seoul, ,

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