Overview

This trial is active, not recruiting.

Condition advanced colorectal cancer
Treatment tkcell
Phase phase 1/phase 2
Sponsor Binex
Start date January 2009
End date January 2010
Trial size 86 participants
Trial identifier NCT00854971, BX-TK-002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
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
(Active Comparator)
FOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times
tkcell TKCell
Biological/Vaccine: TKCell

Primary Outcomes

Measure
Determine response rate
time frame: within study period

Secondary Outcomes

Measure
Determine safety of combination,time to treatment failure, overall survival time
time frame: within study period

Eligibility Criteria

Male or female participants from 19 years up to 80 years old.

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

Additional Information

Official title 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
Principal investigator Seok-Goo Cho, M.D, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Binex.