Efficacy Study of TKcell in Advanced Gastric Cancer

May 15, 2009 updated by: Binex

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Banpo-Dong, Seoul, Korea, Republic of, 137-701
        • The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • NKCell
  • FOLFOX-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine response rate
Time Frame: within study period
within study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine safety of combination,time to treatment failure, overall survival time
Time Frame: within study period
within study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Binex

Investigators

  • Principal Investigator: Seok-Goo Cho, M.D, Ph.D, The Catholic Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BX-TK-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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