Efficacy Study of TKcell in Advanced Gastric Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Binex
ClinicalTrials.gov Identifier:
NCT00854854
First received: February 27, 2009
Last updated: May 15, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer


Condition Intervention Phase
Advanced Gastric Cancer
Biological: TKCell
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Binex:

Primary Outcome Measures:
  • Determine response rate [ Time Frame: within study period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine safety of combination,time to treatment failure, overall survival time [ Time Frame: within study period ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: January 2009
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
  • 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 Comparator: Active

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

and chemotherapy schedule

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:
  • TKCell
  • NKCell
  • FOLFOX-4

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854854

Locations
Korea, Republic of
The catholic University of korea
Banpo-Dong, Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Binex
Investigators
Principal Investigator: Seok-Goo Cho, M.D, Ph.D The Catholic Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Park, Eun-Jin / RN, CRM(clinical research manager)
ClinicalTrials.gov Identifier: NCT00854854     History of Changes
Other Study ID Numbers: BX-TK-001
Study First Received: February 27, 2009
Last Updated: May 15, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Binex:
NKCell
FOLFOX-4
gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 17, 2014