Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood

Study Overview
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Brief Summary
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This study will access the safety and efficacy of the Viatar™ Oncopheresis System to remove a meaningful quantity of circulating tumor cells from the blood of subjects' with breast, colon or prostate solid tumor cancers in a single treatment. CTC reduction will be measured as the change in circulating tumor cells as determined before and after treatment.

Official Title
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Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood

Conditions
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Metastatic Cancer

Intervention / Treatment
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* Device: Oncopheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of breast, colon or prostate cancer No prior cancer therapy or failed first line therapy >= 25 CTC per 7.5 mL of blood within 1 week prior to oncopheresis treatment > 1 month life expectancy Adequate baseline hematological function as assessed by the following laboratory values: Hemoglobin > 9 g/dl Platelets > 100,000/mm3 WBC > 3,000/mm3 Absolute Neutrophil Count > 1,500/mm3 Exclusion Criteria: Coagulation disorders and/or a history of thromboembolic complications, including known hypersensitivity to citrate: e.g., abnormal platelet count, prothrombin time and partial activated thromboplastin time and with a history of deep vein thrombus or pulmonary embolism Patients with known immunodeficiency virus (HIV)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will be their own controls
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic Breast, Colon and Prostate Cancer<br>Metastatic breast, colon or prostate cancer patients will have their CTC levels determined on 3 days before treatment with the Viatar Oncopheresis System to establish a baseline value, a pretreatment value, a post treatment value and on 4 additional instances over a period of 7 days post treatment to establish a CTC rebound profile using a validated CTC enumeration system. | Device: Oncopheresis<br>* Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Circulating Tumor Cells | % change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System | % change will be determined on the day of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune system activation | To assess the effect of oncopheresis on immune system activation | Immune system activation biomarkers will be followed for 7 days post treatment |