Laboratory Testing for Tie-2 Expressing Monocytes (TEMs) in Blood

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01543841

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in healthy individuals and in people with cancer. These cells may play a role in the growth of blood vessels (veins/arteries), and may be particularly important in the growth of blood vessels that supply tumours. Understanding how these cells work may therefore help researchers to develop cancer treatments that starve tumors of their blood supply.

This research study involves an analysis of the behaviour of blood cells in response to different drugs in a test tube. The goal is to develop tests that can then be used to monitor patients treated with drugs that target blood vessel growth.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer Healthy

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

A Laboratory Evaluation of Tie-2 Expressing Monocytes (TEMs) in Healthy Volunteers and Patients With Advanced Cancer

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Advanced Cancer Patients with histologically confirmed metastatic or unresectable solid tumors will have one tube of whole blood (~6mL) collected at the time of venipuncture for routine sample collection. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis.
Healthy Volunteers Eligible volunteers will have one tube of whole blood (~6mL) collected. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis.

Outcome Measures

Primary Outcome Measures

Characterize the in vitro response of circulating myeloid cells to angiopoeitins-1 and 2 (ANG1 and 2) in the presence or absence of pharmacologic inhibitors [1 year]
This is an observational correlative laboratory protocol in which one tube of blood from healthy volunteers and cancer patients will be collected to perform in vitro stimulation of TEMs with ANG1 and 2 and flow cytometry analysis, which could serve as a biomarker for future ANG directed therapies. The results of this study will contribute to an improved understanding of ANG-TIE2 signaling in TEMs. Furthermore, this study will contribute directly to the development and optimization of protocols that will be applied a separate Phase I NCI trial of AMG 386 and temsirolimus.

Secondary Outcome Measures

Develop and optimize flow cytometry analyses [1 year]
This will comprise correlative studies in a separate upcoming Phase I clinical trial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteers
Ability to understand and the willingness to sign a written informed consent document.
Patients with advancer cancer
Participants must have histologically confirmed metastatic or unresectable solid tumors.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Healthy volunteers
History of cancer within the past 5 years
Major medical condition undergoing active therapy
Patients with advancer cancer
Active hematologic malignancy (leukemia, lymphoma, myeloproliferative disorder).
Active treatment on a Phase I clinical trial