Trial | NCT00854854  Report issue

Title

Efficacy Study of TKcell in Advanced Gastric 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 Gastric Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    94
The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer
Study Started
Jan 31
2009
Primary Completion
Jan 31
2010
Anticipated
Study Completion
Jul 31
2010
Anticipated
Last Update
May 18
2009
Estimate

Biological TKCell

TKCell 150ml IV for 7times after each FOLFOX-4 regimen : From the second cycle of FOLFOX4(start Day1),TKCell is administered in Day3 and Day8.In the third cycle of FOLFOX4(Day1),TKCell is administered in Day3 and Day8.In the fourth cycle of FOLFOX4(Day1),TKCell is administered in Day8.In the fifth cycle of FOLFOX4(Day1),TKCell is administered in Day8.In the sixth cycle of FOLFOX4(Day1),TKCell is administered in Day8

  • Other names: NKCell, FOLFOX-4

Control No Intervention

Oxaliplatin infusion (100mg/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

Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times and chemotherapy schedule

Criteria 

Inclusion Criteria:

Written informed consent.
Diagnosis of histologically confirmed adenocarcinoma of the gastric
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