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Efficacy Study of TKcell in Advanced Gastric Cancer

Primary Purpose

Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
TKCell
Sponsored by
Binex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring NKCell, FOLFOX-4, gastric cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The catholic University of korea

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Active

Arm Description

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

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

Outcomes

Primary Outcome Measures

Determine response rate

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2009
Last Updated
May 15, 2009
Sponsor
Binex
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1. Study Identification

Unique Protocol Identification Number
NCT00854854
Brief Title
Efficacy Study of TKcell in Advanced Gastric Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
July 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Binex

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Gastric Cancer
Keywords
NKCell, FOLFOX-4, gastric cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times and chemotherapy schedule
Intervention Type
Biological
Intervention Name(s)
TKCell
Other Intervention Name(s)
NKCell, FOLFOX-4
Intervention Description
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
Primary Outcome Measure Information:
Title
Determine response rate
Time Frame
within study period
Secondary Outcome Measure Information:
Title
Determine safety of combination,time to treatment failure, overall survival time
Time Frame
within study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seok-Goo Cho, M.D, Ph.D
Organizational Affiliation
The Catholic Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The catholic University of korea
City
Banpo-Dong
State/Province
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.bi-nex.com/
Description
Click here for more information about this study.

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Efficacy Study of TKcell in Advanced Gastric Cancer

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