Efficacy Study of TKcell in Advanced Colorectal Cancer

Phase 1

• Conditions: Advanced Colorectal Cancer
• Interventions: Biological: TKCell

• Registration Number: NCT00854971
• Lead Sponsor: Binex

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-28
• Status Verified: 2009-03
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18
• Primary Completion: 2010-01
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Determine response rate	within study period

Secondary Outcome Measures

Name	Time	Method
Determine safety of combination,time to treatment failure, overall survival time	within study period

Trial Locations

Locations (1)

The Catholic University of Korea; 🇰🇷 Seoul, Banpo-dong, Korea, Republic of