Autologous Killer Cell Therapy in Colon Cancer Patients

Study Overview
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Brief Summary
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This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.

Official Title
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Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients

Conditions
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Colon Cancer Stage IV

Intervention / Treatment
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* Biological: Cytokine-induced killer cell
* Other: Chemotherapy AND/OR Radiation Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed colorectal cancer at stage IV ECOG performance status 0-2 Adequate cardiac/renal/hepatic function Adequate bone marrow function (blood cell count) Exclusion Criteria: Patients that have received prior chemotherapy or immune cell therapy Patients that have previously participated in another clinical trial History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis Presence of Active infections Patients with immunodeficiencies, autoimmunities, or severe allergies Receiving immunosuppressive regimens

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIK Intervention plus routine treatment<br>Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion | Biological: Cytokine-induced killer cell<br>* Immune-cell therapy with CIK cells<br>* Other names: CIK;Other: Chemotherapy AND/OR Radiation Therapy<br>* Routine treatments for colon cancer patients according to their stage<br>|
| Active Comparator: Control<br>Patients who receive routine treatments only (chemotherapy, radiation therapy) | Other: Chemotherapy AND/OR Radiation Therapy<br>* Routine treatments for colon cancer patients according to their stage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of administering CIK cells plus chemotherapy | Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion | one month post infusion | 
| Progression-free Survival (PFS) | The time from treatment initiation day to first documented progressive disease or death due to disease. | 2 years | 
| Time to progression (TTP) | the time from randomization until cancer progression, not including death. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | The length of time that the patients are still alive at a defined period of time after treatment | 2 years | 
| Patient quality of life | Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire | each 3 months for 2 years |