Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
86 participants
INTERVENTIONAL
2009-01-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control
Oxaliplatin infusion (85mg/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
No interventions assigned to this group
Active
FOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10\^9 cells, IV route, 7 times
TKCell
Biological/Vaccine: TKCell
Interventions
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TKCell
Biological/Vaccine: TKCell
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of histologically confirmed adenocarcinoma of the colorectal
* 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
* 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
19 Years
80 Years
ALL
No
Sponsors
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Binex
INDUSTRY
Responsible Party
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CRM(clinical research manager)
Principal Investigators
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Seok-Goo Cho, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The Catholic Medical Center
Locations
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The Catholic University of Korea
Seoul, Banpo-dong, South Korea
Countries
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Related Links
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(Click here for more information about this study.)
Other Identifiers
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BX-TK-002
Identifier Type: -
Identifier Source: org_study_id
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