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

Phase 1

• Conditions: Metastatic Cancer
• Interventions: Device: Oncopheresis

• 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

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31
• Study Start: 2018-09
• Primary Completion: 2019-04
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic Breast, Colon and Prostate Cancer	Oncopheresis	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.

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