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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03058809
• Other study ID #: T30-0002
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2018
• Est. completion date: May 2019

Study information

• Verified date: May 2018
• Source: Viatar LLC
• Contact: Michael A Patz
• Phone: 9787128210
• Email: michael.patz[@]viatarctcsolutions.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Viatar LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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