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

Primary Purpose

Prostate Cancer, Renal Cell Carcinoma, Bladder Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mesenchymal-marker based ferrofluid (c-MET)
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 metastatic lesions, or clinically symptomatic with metastatic disease.
  3. Progression of disease on or following the most recent treatment as evidenced 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, palpable lesions, pleural effusions, or ascites in absence of radiographic progression
  4. Enrollment prior to the initiation of a new systemic therapy.
  5. Age > 18 years.
  6. Ability to understand and the willingness to sign a written informed consent document.

Gastric cancer (including gastroesophageal junction) patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

  1. Histologically confirmed diagnosis of invasive gastric or distal esophageal adenocarcinoma.
  2. Clinical or radiographic evidence of metastatic disease.
  3. Evidence of disease progression on or following the most recent therapy, as defined by one of the following:

    • 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, palpable lesions, pleural effusions, or ascites in absence of radiographic progression
  4. Enrollment prior to the initiation of a new systemic therapy.
  5. Age > 18 years.
  6. Ability to understand and the willingness to sign a written informed consent document.

Colorectal 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 colorectal adenocarcinoma.
  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:

    • 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, palpable lesions, pleural effusions, or ascites in absence of radiographic progression
  4. Enrollment prior to the initiation of a new systemic therapy.
  5. Age > 18 years.
  6. Ability to understand and the willingness to sign a written informed consent document.

Pancreatic 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 pancreatic adenocarcinoma.
  2. Clinical or radiographic evidence of metastatic disease.
  3. Enrollment prior to the initiation of a new systemic therapy.
  4. Age > 18 years.
  5. Ability to understand and the willingness to sign a written informed consent document.

Advanced, MET amplified, solid tumor patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

  1. Histologically confirmed diagnosis of cancer (any kind)
  2. MET gene amplification by FISH, CISH, rtPCR, or other assay as determined by the investigator.
  3. Clinical or radiographic evidence of metastatic disease.
  4. Age > 18 years.
  5. Ability to understand and the willingness to sign a written informed consent document.

Non-Small Cell Lung Cancer (NSCLC) patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

  1. Histologically confirmed diagnosis of invasive non-small cell carcinoma of the lung (includes adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous, and carcinomas with pleomorphic, sarcomatoid, or sarcomatous elements; does not include carcinoid tumor or neuroendocrine carcinoma).
  2. Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
  3. Progression of disease on or following the most recent treatment as evidenced 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. Progression of disease either on or following treatment with an EGFR inhibitor (such as erlotinib, gefitinib, or other EGFR-targeted 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.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any of the following criteria apply:

  1. History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
  2. Treatment with an anthracycline (including mitoxantrone, doxorubicin, epirubicin, and daunorubicin) within 1 week of CTC collection (applicable in prostate and gastric cancer patients), as anthracyclines cause auto-fluorescence of cells.

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Other

Other

Other

Other

Other

Other

Other

Other

Arm Label

Prostate cancer

Renal cell carcinoma

Bladder cancer

Gastric cancer

Colorectal cancer

Pancreatic cancer

Non-small cell lung cancer

Advanced MET amplified solid tumor

Arm Description

Mesenchymal-marker based ferrofluid (c-MET)

Mesenchymal-marker based ferrofluid (c-MET)

Mesenchymal-marker based ferrofluid (c-MET)

Mesenchymal-marker based ferrofluid (c-MET)

Mesenchymal-marker based ferrofluid (c-MET)

Mesenchymal-marker based ferrofluid (c-MET)

Mesenchymal-marker based ferrofluid (c-MET)

Mesenchymal-marker based ferrofluid (c-MET)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in the median number of CTCs
The difference in the median number of CTCs detected by each of the capture methods (novel and standard) will be calculated.
Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics.
Within each method, the patient will be used as the unit of observation to describe the association of number of detectable CTC cells with the following baseline characteristics: TNM staging, site of metastases (e.g., bone, liver, lymph nodes), Gleason sum (for PC), PSA (for PC), the number of prior hormone therapies (in PC), CEA (for colorectal cancer), the use of previous EGFR inhibitors and KRAS mutation status (for colorectal cancer), HER2 status and prior HER2 treatments (for gastric cancer), CA 19-9 (for pancreatic cancer), and number of prior chemotherapies.
Kinetics of CTCs over time during treatment with c-MET targeted therapies
Change is CTCs in patients with MET amplified tumors undergoing treatment with c-MET targeted therapies will be calculated.

Full Information

First Posted
March 3, 2014
Last Updated
July 31, 2017
Sponsor
Duke University
Collaborators
Prostate Cancer Foundation, Janssen Diagnostics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02080650
Brief Title
Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)
Official Title
Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 19, 2016 (Actual)
Study Completion Date
July 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Prostate Cancer Foundation, Janssen Diagnostics, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Renal Cell Carcinoma, Bladder Cancer, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Advanced MET Amplified Solid Tumor

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Arm Title
Renal cell carcinoma
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Arm Title
Bladder cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Arm Title
Gastric cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Arm Title
Colorectal cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Arm Title
Pancreatic cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Arm Title
Non-small cell lung cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Arm Title
Advanced MET amplified solid tumor
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
Device
Intervention Name(s)
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
Device
Intervention Name(s)
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Primary Outcome Measure Information:
Title
Feasibility
Description
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 Measure Information:
Title
Difference in the median number of CTCs
Description
The difference in the median number of CTCs detected by each of the capture methods (novel and standard) will be calculated.
Time Frame
day 1
Title
Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics.
Description
Within each method, the patient will be used as the unit of observation to describe the association of number of detectable CTC cells with the following baseline characteristics: TNM staging, site of metastases (e.g., bone, liver, lymph nodes), Gleason sum (for PC), PSA (for PC), the number of prior hormone therapies (in PC), CEA (for colorectal cancer), the use of previous EGFR inhibitors and KRAS mutation status (for colorectal cancer), HER2 status and prior HER2 treatments (for gastric cancer), CA 19-9 (for pancreatic cancer), and number of prior chemotherapies.
Time Frame
day 1
Title
Kinetics of CTCs over time during treatment with c-MET targeted therapies
Description
Change is CTCs in patients with MET amplified tumors undergoing treatment with c-MET targeted therapies will be calculated.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply: Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted. Clinical or radiographic evidence of metastatic disease. Castrate levels of testosterone (<50 ng/dl) Enrollment prior to the initiation of a new systemic therapy. 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 Age > 18 years. 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: Histologically confirmed diagnosis of invasive renal cell carcinoma (all histologies) Clinical or radiographic evidence of metastatic disease. 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 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. Enrollment prior to the initiation of a new systemic therapy. Age > 18 years. 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: Histologically confirmed diagnosis of invasive bladder transitional cell carcinoma, adenocarcinoma, squamous cell carcinoma, or small cell carcinoma. Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease. Progression of disease on or following the most recent treatment as evidenced 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, palpable lesions, pleural effusions, or ascites in absence of radiographic progression Enrollment prior to the initiation of a new systemic therapy. Age > 18 years. Ability to understand and the willingness to sign a written informed consent document. Gastric cancer (including gastroesophageal junction) patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: Histologically confirmed diagnosis of invasive gastric or distal esophageal adenocarcinoma. Clinical or radiographic evidence of metastatic disease. Evidence of disease progression on or following the most recent therapy, as defined by one of the following: 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, palpable lesions, pleural effusions, or ascites in absence of radiographic progression Enrollment prior to the initiation of a new systemic therapy. Age > 18 years. Ability to understand and the willingness to sign a written informed consent document. Colorectal cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: Histologically confirmed diagnosis of invasive colorectal adenocarcinoma. Clinical or radiographic evidence of metastatic disease. Evidence of disease progression on the current or following the most recent therapy, as defined by one of the following: 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, palpable lesions, pleural effusions, or ascites in absence of radiographic progression Enrollment prior to the initiation of a new systemic therapy. Age > 18 years. Ability to understand and the willingness to sign a written informed consent document. Pancreatic cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: Histologically confirmed diagnosis of invasive pancreatic adenocarcinoma. Clinical or radiographic evidence of metastatic disease. Enrollment prior to the initiation of a new systemic therapy. Age > 18 years. Ability to understand and the willingness to sign a written informed consent document. Advanced, MET amplified, solid tumor patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: Histologically confirmed diagnosis of cancer (any kind) MET gene amplification by FISH, CISH, rtPCR, or other assay as determined by the investigator. Clinical or radiographic evidence of metastatic disease. Age > 18 years. Ability to understand and the willingness to sign a written informed consent document. Non-Small Cell Lung Cancer (NSCLC) patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply: Histologically confirmed diagnosis of invasive non-small cell carcinoma of the lung (includes adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous, and carcinomas with pleomorphic, sarcomatoid, or sarcomatous elements; does not include carcinoid tumor or neuroendocrine carcinoma). Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease. Progression of disease on or following the most recent treatment as evidenced 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 Progression of disease either on or following treatment with an EGFR inhibitor (such as erlotinib, gefitinib, or other EGFR-targeted therapy) Enrollment prior to the initiation of a new systemic therapy. Age > 18 years. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: A patient will not be eligible for inclusion in this study if any of the following criteria apply: History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s). Treatment with an anthracycline (including mitoxantrone, doxorubicin, epirubicin, and daunorubicin) within 1 week of CTC collection (applicable in prostate and gastric cancer patients), as anthracyclines cause auto-fluorescence of cells.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Armstrong, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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

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