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

Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807027
• Other study ID #: IcmLCBT_301
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2008
• Last updated: October 24, 2012
• Start date: December 2008
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Green Cross Cell Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Guri Hospital	Guri	Gyeonggi-Do
Korea, Republic of	Gyunghee University Medical Center	Seoul
Korea, Republic of	Konkuk University	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Seoul Medical Center	Seoul
Korea, Republic of	Seoul Asan Medical Center	Seoul
Korea, Republic of	Yeonsei University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI		Every 3months from the screening	Yes
Secondary	Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS)		Every 3months from the screening	Yes