Efficacy Study of TKcell in Advanced Colorectal Cancer
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 Colorectal Cancer
| Sponsors |
Lead Sponsor: Binex |
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| Source | Binex | ||||||
| Brief Summary | The purpose of this study is to determine efficacy of NKCell in colorectal cancer |
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| Overall Status | Unknown status | ||||||
| Start Date | January 2009 | ||||||
| Completion Date | January 2010 | ||||||
| Primary Completion Date | January 2010 | ||||||
| Phase | Phase 1/Phase 2 | ||||||
| Study Type | Interventional | ||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 86 | ||||||
| Condition | |||||||
| Intervention |
Intervention Type: Biological Intervention Name: TKCell Description: Biological/Vaccine: TKCell Arm Group Label: Active |
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| Eligibility |
Criteria:
Inclusion Criteria: - Written informed consent. - 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: - 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 Gender: All Minimum Age: 19 Years Maximum Age: 80 Years Healthy Volunteers: No |
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| Overall Official |
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| Location |
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| Location Countries |
Korea, Republic of |
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| Verification Date |
March 2009 |
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| Responsible Party |
Name Title: Park, Eun-Jin / Research institute Organization: CRM(clinical research manager) |
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| Has Expanded Access | No | ||||||
| Condition Browse | |||||||
| Number Of Arms | 2 | ||||||
| Arm Group |
Label: control Type: No Intervention Description: 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 Label: Active Type: Active Comparator Description: FOLFOX-4 regimen + Infusion of TKCell(autologous activated lymphocyte) over 2x10^9 cells, IV route, 7 times |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: None (Open Label) |
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