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This study will access the safety and efficacy of the Viatarâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Breast, Colon and Prostate Cancer | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncopheresis | Device | Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components. |
| 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 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael A Patz | Contact | 9787128210 | michael.patz@viatarctcsolutions.com | |
| Steve Keaney | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nigel Murray, MD | Hospital de Carabineros | Principal Investigator |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Subjects will be their own controls
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