Isolation and Culture of Immune Cells and Circulating Tumor Cells From Peripheral Blood and Leukopaks



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/12/2018
Start Date:November 2007
End Date:January 2019
Contact:John Powderly, M.D.
Email:jpowderly@carolinabiooncology.org
Phone:704-947-6599

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A Study to Facilitate Development of an Ex-Vivo Device Platform for Circulating Tumor Cell and Immune Cell Harvesting, Banking, and Apoptosis-Viability Assay

Primary Objective:

This is a study to investigate the feasibility of harvesting, expanding in culture, and
freezing circulating tumor cells and immune cells from cancer patients and healthy
volunteers.


Inclusion Criteria:

- Histological diagnosis of metastatic stage IV or locally advanced (unresectable) stage
III cancer of any solid tumor type. Patients may have been previously treated or chemo
naïve or healthy volunteer

- Age > 18yo

- Life expectancy > 12 weeks

- ECOG Performance Status of 0, 1, 2, or 3 (Appendix 2)

- Screening laboratory values must meet the following criteria:

- WBC ≥2000/µL

- Neutrophils ≥1500/µL

- Platelets >100x103/µL

- Hemoglobin ≥8 g/dL

- Creatinine <2.5 x ULN

- AST ≤2.5 x ULN without, and ≤ 5 x ULN with hepatic metastases

- Bilirubin ≤2 x ULN (except patients with Gilbert's syndrome, who must have total
bilirubin < 3.0 mg/dL)

Exclusion Criteria:

- Primary Hematologic Malignancies (leukemia, lymphoma)

- Patients with any active infection requiring therapy (fever, localizing source) will
be excluded until the infection resolves.

- History of, or a positive test for HIV-1, HIV-2, or HTLV-1 serum antibody, hepatitis B
surface antigen, or hepatitis C positive RNA

- Underlying medical condition that, in the Principal Investigator's or treating
oncologist's opinion, will obscure the interpretation of the patient's safety.
We found this trial at
1
site
9801 W. Kincey Ave
Huntersville, North Carolina 28078
704-947-6599
?
mi
from
Huntersville, NC
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