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

May 29, 2018 updated by: Viatar LLC

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Steve Keaney

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metastatic Breast, Colon and Prostate Cancer
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
Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Circulating Tumor Cells
Time Frame: % change will be determined on the day of treatment
% 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
Time Frame: Immune system activation biomarkers will be followed for 7 days post treatment
To assess the effect of oncopheresis on immune system activation
Immune system activation biomarkers will be followed for 7 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viatar LLC

Investigators

  • Principal Investigator: Nigel Murray, MD, Hospital de Carabineros

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

February 16, 2017

First Submitted That Met QC Criteria

February 20, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T30-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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