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

NCT03058809 | Unknown Phase 1 FDA Device

• 1 other identifier: T30-0002
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immune system activation

  Immune system activation biomarkers will be followed for 7 days post treatment

Study Arms (1)

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.

Device: Oncopheresis

Interventions

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.

Metastatic Breast, Colon and Prostate Cancer

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Viatar LLC: lead

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nigel Murray, MD

  Hospital de Carabineros

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael A Patz

CONTACT

9787128210; michael.patz@viatarctcsolutions.com

Steve Keaney

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be their own controls

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: September 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 31, 2018

Record last verified: 2018-05