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


N/A
19 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Bryan Greene, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Carolina BioOncology Institute

Authority:

United States: Institutional Review Board

Study ID:

Biocytics0001

NCT ID:

NCT00571389

Start Date:

November 2007

Completion Date:

June 2012

Related Keywords:

  • Metastatic Cancer
  • Stage IV
  • Advanced Stage III
  • Neoplastic Cells, Circulating
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Carolina BioOncology InstituteHuntersville, North Carolina  28078