Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
- Conditions
- Metastatic Cancer
- Registration Number
- NCT03058809
- Lead Sponsor
- Viatar LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
-
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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Circulating Tumor Cells % change will be determined on the day of treatment % change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System
- Secondary Outcome Measures
Name Time Method Immune system activation Immune system activation biomarkers will be followed for 7 days post treatment To assess the effect of oncopheresis on immune system activation