Clinical trial NCT00807027: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glioblastoma
Keywords: Glioblastoma
Newly diagnosed Glioblastoma
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2008-12-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: MRI
timeFrame: Every 3months from the screening
Secondary outcomes:
measure: Overall survival, therapy reaction, EORTC QLQ-C30, and Karnofsky Performance Status (KPS)
timeFrame: Every 3months from the screening
Other outcomes:
Locations:
city: Guri
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Gyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Yeonsei University Medical Center
Study officials:
affiliation: Hanyang University
name: Chunghyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: