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Comprehensive Gene Sequencing in Guiding Treatment Recommendations Patients With Metastatic or Recurrent Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Erin Macrae, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01987726
First received: November 13, 2013
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

This pilot clinical trial studies comprehensive gene sequencing in guiding treatment recommendations in patients with metastatic or recurrent solid tumors. Studying samples of blood and tissue from patients with cancer in the laboratory may improve the ability to plan treatment.


Condition Intervention
Recurrent Breast Cancer
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IV Breast Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Other: cytology specimen collection procedure
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Decision Impact Analysis of Foundation Medicine's Next Generation Sequencing Test in Advanced Solid Tumor Malignancies

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Feasibility of NGS on metastatic solid tumor tissue, in terms of number of patients screened, FMI test attempted, FMI test successful, and FMI tests results released to physicians [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Summary tables will be generated.

  • Feasibility of NGS result-based non-FDA-approved treatment plan, measured by reasons for ability or inability to receive an anti-cancer agent [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Summary tables will be generated.

  • Availability of recommended experimental regimens via clinical trials [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
  • Proportion of patients who have one recommended therapy [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    The proportion of patients who have one recommended therapy recommended will be assessed and compared with the proportion who have multiple options recommended. Summarized, and estimates derived along with corresponding 95% confidence intervals.

  • Proportion of patients who have multiple options recommended [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    The proportion of patients who have one recommended therapy recommended will be assessed and compared with the proportion who have multiple options recommended. Summarized, and estimates derived along with corresponding 95% confidence intervals.


Secondary Outcome Measures:
  • Presence of any oncogene or tumor suppressor gene mutations or amplifications identified by NGS on tumor tissue in each cohort [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Observational (NGS, FMI testing)

PART I: Within 10 weeks of beginning a treatment regimen, tumor tissue samples, Blood Collection and CTCs(Circulating tumor cell)from patients are collected for NGS and FMI testing, respectively. Patients remain on current line of therapy until a change in treatment is warranted. The physician's treatment recommendation is documented prior to the release of the FMI results.

PART II: Physicians are furnished with FMI test results when patients become eligible for a change in therapy and new treatment recommendations are documented. Treatment is dependent on preferences of the physician, patient, and/or results of the FMI test.

Other: cytology specimen collection procedure
Undergo collection of CTCs for NGS and FMI testing, respectively.The most recent tumor sample collected from the patient with enough tissue to perform NGS testing will be selected. Tumor from a metastatic or recurrent cancer lesion is preferred but not required. Tumor collection is for standard of care purposes and thus not detailed in this protocol.For each tissue specimen, a representative H&E stained section will be evaluated by a qualified pathologist to confirm the histopathological diagnosis of cancer and to make a quantitative estimate of the proportion of the specimen that is tumor-related cells and the proportion that is non-tumor cells.
Other Name: cytologic sampling
Other: laboratory biomarker analysis
2 tubes of 7.5 mL blood samples each will be collected at time tumor tissue is sent to FMI and sent to Cynvenio Biosystems, Inc for CTC isolation and analysis. Patient CTCs will be recovered using Cynvenio CTC flow cell technology (Cynvenio Biosystems, Inc.) and enumerated using a combination of CD45, DAPI and cytokeratin staining.1 DNA will be isolated from CTCs and amplified using Φ-29 whole genome amplification (GE Healthcare). Sequencing to be performed by FoundationOne™ protocol.
Other Names:
  • Correlative studies
  • blood samples

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility and logistics associated with a clinical trial utilizing the Foundation Medicine Incorporated (FMI) test in an academic therapeutic setting.

II. To determine the proportion of patients who will receive a cancer-related therapy based on the results provided by the FMI test.

SECONDARY OBJECTIVES:

I. To explore and report estimates of progression free survival (PFS) of the regimen administered after the FMI test results are revealed and the PFS of the most recent regimen administered before the FMI test results were received.

II. To determine the feasibility of performing Next Generation Sequencing (NGS) on metastatic tumor tissue.

III. To determine the feasibility of administering cancer-related drugs that are proposed by the results of NGS that are not Food and Drug Administration (FDA)-approved for a patient's specific cancer diagnosis.

IV. To collect and report the molecular alterations discovered by NGS of advanced breast and colorectal cancer.

V. To determine in an exploratory manner the concordance of the genomic alterations detected by the FMI test in circulating tumor cells (CTCs) to the genomic alterations detected by FMI test in tumor tissues collected from the same patient.

OUTLINE:

PART I: Within 10 weeks of beginning a treatment regimen, tumor tissue samples and CTCs from patients are collected for NGS and FMI testing, respectively. Patients remain on current line of therapy until a change in treatment is warranted. The physician's treatment recommendation is documented prior to the release of the FMI results.

PART II: Physicians are furnished with FMI test results when patients become eligible for a change in therapy and new treatment recommendations are documented. Treatment is dependent on preferences of the physician, patient, and/or results of the FMI test.

After completion of study, patients are followed up for at least 18 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are able to understand and provide written informed consent (most recent patient informed consent form) prior to initiation of any study-specific procedures
  • Patients are diagnosed with recurrent or metastatic a solid tumor cancer; the first patients to be enrolled will have a diagnosis of breast cancer (Cohort 1) or colorectal cancer (Cohort 2)
  • Patients may enter this study at any line of therapy
  • Patients must have a tumor sample available for NGS testing
  • Patients are within 10 weeks of starting their current line of therapy and enrolled before their 1st computed tomography (CT) scan
  • Have an expected survival of >= 3 months, as estimated by the treating oncologist
  • Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2

Exclusion Criteria:

  • Are pregnant or nursing women
  • Are unable to comply with requirements of the study
  • Have a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987726

Contacts
Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Erin Macrae, MD 614-366-8541 Erin.Macrae@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Erin M. Macrae    614-366-8541    Erin.macrae@osumc.edu   
Principal Investigator: Erin M. Macrae, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Foundation Medicine
Investigators
Principal Investigator: Erin Macrae, MD Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Erin Macrae, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01987726     History of Changes
Other Study ID Numbers: OSU-12067, NCI-2013-00872
Study First Received: November 13, 2013
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Solid Tumor Malignancies

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014