NCT00854854

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 18, 2009

Status Verified

March 1, 2009

Enrollment Period

1 year

First QC Date

February 27, 2009

Last Update Submit

May 15, 2009

Conditions

Advanced Gastric Cancer

Keywords

NKCellFOLFOX-4gastric cancer

Outcome Measures

Primary Outcomes (1)

  • Determine response rate

    within study period

Secondary Outcomes (1)

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

    within study period

Study Arms (2)

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

Biological: TKCell

Interventions

TKCellBIOLOGICAL

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

Also known as: NKCell, FOLFOX-4
Active

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The catholic University of korea

Banpo-dong, Seoul, 137-701, South Korea

Location

Related Links

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Seok-Goo Cho, M.D, Ph.D

    The Catholic Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 3, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

July 1, 2010

Last Updated

May 18, 2009

Record last verified: 2009-03

Locations

KR(1)