Efficacy Study of TKcell in Advanced Gastric Cancer

Advanced Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00854854
• Other study ID #: BX-TK-001
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• First received: February 27, 2009
• Last updated: May 15, 2009
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: March 2009
• Source: Binex
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 94
• Est. completion date: July 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	The catholic University of korea	Banpo-Dong	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Binex

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine response rate		within study period	Yes
Secondary	Determine safety of combination,time to treatment failure, overall survival time		within study period	Yes

External Links

•   Click here for more information about this study.