Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)

Brief summary public domain (ClinicalTrials.gov)

This pilot study will aim to determine whether circulating tumor cells (CTCs) can be captured using the novel cMET based ferrofluid. The primary objective of this pilot study will be to describe the numbers of c-MET expressing cells that can be detected by the c-MET CTC capture technique. These data will be separated by disease site. The investigator will also describe the detection rates of both the c-MET CTC capture and the EpCAM CTC capture techniques in each patient, also separated by disease site.

Intervention public domain (ClinicalTrials.gov)

Device: Mesenchymal-marker based ferrofluid (c-MET).

Intervention public domain (ClinicalTrials.gov)

Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid.

Arm public domain (ClinicalTrials.gov)

Prostate cancer (other): Mesenchymal-marker based ferrofluid (c-MET)

Arm public domain (ClinicalTrials.gov)

Renal cell carcinoma (other): Mesenchymal-marker based ferrofluid (c-MET)

Arm public domain (ClinicalTrials.gov)

Bladder cancer (other): Mesenchymal-marker based ferrofluid (c-MET)

Arm public domain (ClinicalTrials.gov)

Gastric cancer (other): Mesenchymal-marker based ferrofluid (c-MET)

Arm public domain (ClinicalTrials.gov)

Colorectal cancer (other): Mesenchymal-marker based ferrofluid (c-MET)

Arm public domain (ClinicalTrials.gov)

Pancreatic cancer (other): Mesenchymal-marker based ferrofluid (c-MET)

Primary outcome public domain (ClinicalTrials.gov)

Feasibility. Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects within each disease site. Time frame: day 1.

Secondary outcome public domain (ClinicalTrials.gov)

Difference in the median number of CTCs. Time frame: day 1.

Secondary outcome public domain (ClinicalTrials.gov)

Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics.. Time frame: day 1.

Secondary outcome public domain (ClinicalTrials.gov)

Kinetics of CTCs over time during treatment with c-MET targeted therapies. Time frame: 8 weeks.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply: 1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted. 2. Clinical or radiographic evidence of metastatic disease. 3. Castrate levels of testosterone (\<50 ng/dl) 4. Enrollment prior to the initiation of a new systemic therapy. 5. Evidence of disease progression on or following most recent therapy as evidenced by either of the following: * Two consecutive PSA levels greater than the PSA nadir achieved on ADT and most recent therapy, separated by greater than one week * Radiographic evidence of disease progression as defined by new bone scan lesions or growth of soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes). * Clinical progression of disease with cutaneous lesions or palpable lesions in absence of radiographic progression 6. Age \> 18 years. 7. Ability to understand and the willingness to sign a written informed consent document. Renal cell carcinoma patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: 1. Histologically confirmed diagnosis of invasive renal cell carcinoma (all histologies) 2. Clinical or radiographic evidence of metastatic disease. 3. Evidence of disease progression on the current or following the most recent therapy, as defined by one of the following: * A new soft tissue/visceral/lymph node/bone metastatic lesion * Growth of existing soft tissue/visceral/lymph node/bone metastases as determined by the investigator * Clinical progression of disease with cutaneous lesions or palpable lesions in absence of radiographic progression 4. For clear cell carcinoma, refractory to treatment with VEGF inhibitors as defined by progression on VEGF therapy within 1 year of starting VEGF therapy. For non-clear cell histologies, any line of systemic therapy. 5. Enrollment prior to the initiation of a new systemic therapy. 6. Age \> 18 years. 7. Ability to understand and the willingness to sign a written informed consent document. Bladder cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: 1. Histologically confirmed diagnosis of invasive bladder transitional cell carcinoma, adenocarcinoma, squamous cell carcinoma, or small cell carcinoma. 2. Metastatic disease with either bone or visceral …

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 62 participants (actual).