Isolation and Culture of Circulating Tumor Cells From Peripheral Blood

The population of patients to be enrolled for this study will be adults (males and females) with histological proven metastatic solid tumors seen for routine cancer care at participating community cancer clinic sites. Patients on clinical trials with experimental study drugs will be allowed to participate in this observational pilot study.

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.
• 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.