Back to resultsEvaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
Primary Purpose
Metastatic Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Oncopheresis
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metastatic Breast, Colon and Prostate Cancer
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Circulating Tumor Cells
% change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System
Secondary Outcome Measures
Immune system activation
To assess the effect of oncopheresis on immune system activation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03058809
Brief Title
Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
Official Title
Evaluation of the Saftey and Efficacy of the Viatar™ Oncopheresis System in Removing Circulating Tumor Cells From Whole Blood
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viatar LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Subjects will be their own controls
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metastatic Breast, Colon and Prostate Cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Oncopheresis
Intervention Description
Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.
Primary Outcome Measure Information:
Title
Change in Circulating Tumor Cells
Description
% change in enumerated circulating tumor cells after treatment with Viatar Oncopheresis System
Time Frame
% change will be determined on the day of treatment
Secondary Outcome Measure Information:
Title
Immune system activation
Description
To assess the effect of oncopheresis on immune system activation
Time Frame
Immune system activation biomarkers will be followed for 7 days post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Patz
Phone
9787128210
Email
michael.patz@viatarctcsolutions.com
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Keaney
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Murray, MD
Organizational Affiliation
Hospital de Carabineros
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
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