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

Primary Purpose

Glioblastoma

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Activated T lymphocyte(Immuncell-LC)

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Newly diagnosed Glioblastoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Hanyang University Guri Hospital
Gyunghee University Medical Center
Konkuk University
Korea University Anam Hospital
Samsung Seoul Medical Center
Seoul Asan Medical Center
Yeonsei University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Test Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

MRI

Secondary Outcome Measures

Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS)

Full Information

NCT ID

NCT00807027

First Posted

December 10, 2008

Last Updated

October 24, 2012

Sponsor

GC Cell Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00807027

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GC Cell Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

Glioblastoma, Newly diagnosed Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Arm Title

Test Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Activated T lymphocyte(Immuncell-LC)

Intervention Description

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)

Primary Outcome Measure Information:

Title

MRI

Time Frame

Every 3months from the screening

Secondary Outcome Measure Information:

Title

Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS)

Time Frame

Every 3months from the screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunghyun Kim, MD

Organizational Affiliation

Hanyang University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hanyang University Guri Hospital

City

Guri

State/Province

Gyeonggi-Do

Country

Korea, Republic of

Facility Name

Gyunghee University Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Konkuk University

City

Seoul

Country

Korea, Republic of

Facility Name

Korea University Anam Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Samsung Seoul Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Seoul Asan Medical Center

City

Seoul

Country

Korea, Republic of

Facility Name

Yeonsei University Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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