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 | 
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.
			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.
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