Efficacy Study of TKcell in Advanced Colorectal Cancer

Evaluating the Safety and Efficacy of Combination Therapy With FOLFOX-4 and TKcell Therapy Versus FOLFOX-4 Alone in Patients With Recurrent, Unresectable and Advanced Colorectal Cancer

Sponsors

Lead Sponsor: Binex

Source Binex
Brief Summary

The purpose of this study is to determine efficacy of NKCell in colorectal cancer

Overall Status Unknown status
Start Date January 2009
Completion Date January 2010
Primary Completion Date January 2010
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Determine response rate within study period
Secondary Outcome
Measure Time Frame
Determine safety of combination,time to treatment failure, overall survival time within study period
Enrollment 86
Condition
Intervention

Intervention Type: Biological

Intervention Name: TKCell

Description: Biological/Vaccine: TKCell

Arm Group Label: Active

Eligibility

Criteria:

Inclusion Criteria: - Written informed consent. - Diagnosis of histologically confirmed adenocarcinoma of the colorectal - ECOG performance status of 0 - 2 - At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in physical examination - Adequate liver, renal, bone marrow functions as evidence by the following; - Absolute neutrophil count > 1.5 x 109/L; platelets > 7.5 x 109/L; Bilirubin less than 2 mg/dL ASAT and/or ALAT < 5 UNL; serum creatinine ≤ 2 ULN - Minimum life expectancy of 12 weeks - Effective contraception for both male and female subjects if the risk of conception exists Exclusion Criteria: - Brain metastasis and/or leptomeningeal disease (known or suspected) - Previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment. - Previous oxaliplatin-based chemotherapy - Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy - HIV antibody (+), Chronic hepatitis - Uncontrolled infection - Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception - Clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia - Known hypersensitivity reaction to any of the components of the treatment. - Pregnancy (absence to be confirmed by ß-hCG test) or lactation period - Participation in another clinical study within the 30 days before randomization - Significant disease which, in the investigator's opinion, would exclude the subject from the study

Gender: All

Minimum Age: 19 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Seok-Goo Cho, M.D, Ph.D Principal Investigator The Catholic Medical Center
Location
Facility: The Catholic University of Korea
Location Countries

Korea, Republic of

Verification Date

March 2009

Responsible Party

Name Title: Park, Eun-Jin / Research institute

Organization: CRM(clinical research manager)

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: control

Type: No Intervention

Description: Oxaliplatin infusion (85mg/m2) on days 1 and 15 (every 2 weeks) 5-FU bolus + infusions (400 mg/m2) on days 1, 2, 15 and 16 LV infusions (200 mg/m2) on days 1, 2, 15 and 16

Label: Active

Type: Active Comparator

Description: FOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov