Trial | NCT00854971  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    86
The purpose of this study is to determine efficacy of NKCell in colorectal cancer
Study Started
Jan 31
2009
Primary Completion
Jan 31
2010
Anticipated
Study Completion
Jan 31
2010
Anticipated
Last Update
May 18
2009
Estimate

Biological TKCell

Biological/Vaccine: TKCell

  • Other names: NKCell, FOLFOX-4

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

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
No Results Posted