Efficacy Study of TKcell in Advanced Colorectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Binex.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Binex
ClinicalTrials.gov Identifier:
NCT00854971
First received: February 28, 2009
Last updated: May 15, 2009
Last verified: March 2009

February 28, 2009
May 15, 2009
January 2009
January 2010   (final data collection date for primary outcome measure)
Determine response rate [ Time Frame: within study period ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00854971 on ClinicalTrials.gov Archive Site
Determine safety of combination,time to treatment failure, overall survival time [ Time Frame: within study period ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Colorectal Cancer
Biological: TKCell
Biological/Vaccine: TKCell
Other Names:
  • TKCell
  • NKCell
  • FOLFOX-4
  • No Intervention: control
    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: Active
    FOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times
    Intervention: Biological: TKCell
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
86
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
19 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00854971
BX-TK-002
No
Park, Eun-Jin / Research institute, CRM(clinical research manager)
Binex
Not Provided
Principal Investigator: Seok-Goo Cho, M.D, Ph.D The Catholic Medical Center
Binex
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP