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

Viatar

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Metastatic Cancer

Treatments: Device: Oncopheresis

Study type: Interventional

Funder types: Industry

Identifiers

NCT03058809

T30-0002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Metastatic Breast, Colon and Prostate Cancer

Experimental group

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.

Treatment:

Device: Oncopheresis