Efficacy Study of TKcell in Advanced Colorectal Cancer

NCT00854971 | Unknown Phase 1

• 1 other identifier: BX-TK-002
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Colorectal Cancer

Keywords

NKCell; FOLFOX-4; advanced or unresectable colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Determine response rate

  within study period

Secondary Outcomes (1)

• Determine safety of combination,time to treatment failure, overall survival time

  within study period

Study Arms (2)

control

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

ACTIVE COMPARATOR

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

Biological: TKCell

Interventions

TKCell BIOLOGICAL

Biological/Vaccine: TKCell

Also known as: NKCell, FOLFOX-4

Active

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Binex: lead

Study Sites (1)

The Catholic University of Korea

Seoul, Banpo-dong, 137-701, South Korea

Location

Related Links

• (Click here for more information about this study.)

MeSH Terms

Interventions

Folfox protocol

Study Officials

• Seok-Goo Cho, M.D, Ph.D

  The Catholic Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2009
• First Posted: March 3, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: May 18, 2009

Record last verified: 2009-03

Locations

KR (1)