A Pilot Study to Facilitate Development of an Ex Vivo Device Kit for Circulating Tumor Cell Harvesting, Banking, and Apoptosis-Viability Assay
- 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.
- 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)
- 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.