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C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adenovirus-p53 transduced dendritic cell vaccine
1-methyl-D-tryptophan
Carbon C 11 alpha-methyltryptophan
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast - male, breast - female, metastatic, invasive

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must be enrolled on the NCI 8461/MCC 16025 study.
  • Consent for participation in this companion imaging study and be able to successfully complete a minimum of two AMT PET/CT scans.

Exclusion Criteria:

  • Patients must not meet any of the exclusion criteria for the NCI 8461/ MCC 16025 study.
  • Not have any medical conditions prohibiting the successful completion of a minimum of two AMT PET/CT scans.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Radiotherapy

    Arm Description

    AMT positron emission tomography with integrated computed tomography (PET/CT)scanning in metastatic breast cancer patients to identify tumors with increased AMT uptake due to up-regulated IDO expression.

    Outcomes

    Primary Outcome Measures

    Occurrence of Detected Changes in Regions of Interest (ROIs)
    Changes in C-11 AMT uptake and localization (measured by SUV) between baseline and approximately 4 days after initiation of treatment. The primary objective is to determine whether such changes can be detected in regions of interest (ROIs) using PET/CT imaging in patients with metastatic breast cancer enrolled in NCI 8461/ MCC16025. The SUV values in identified regions of interest (ROIs) for each patient will be compared over time between baseline and approximately 4 days after initiation of treatment, and after completion of the protocol treatment. The analysis will be largely exploratory and descriptive as the sample size and study design will likely preclude an adequate/definitive statistical conclusion of SUV values between the two time points.

    Secondary Outcome Measures

    Number of Participants with Clinical Response
    Clinical responses based on Response Evaluation Criteria In Solid Tumors [RECIST] criteria, to 1-MT plus the Ad.p53 DC vaccine.
    Number of Participants with Presence of IDO ImmunoHistoChemistry (IHC) Expression
    Presence of immuno-modulatory enzyme indoleamine 2,3-dioxygenase (IDO) IHC expression (positive vs. negative as described in NCI 8461/MCC 16025) in the assayed tumor sample.
    Number of Participants with Immune Response
    Immune response to the vaccine (by ELISPOT criteria as described in NCI 8461/MCC 16025). The secondary endpoint immunologic response is defined as IFN-γ p53 T cell specific ELISPOT assay count measured, being ≥ 2 SDs above the baseline for a patient.
    Number of Participants with Adverse Events
    Examine toxicity data of the protocol treatment according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0.

    Full Information

    First Posted
    February 22, 2011
    Last Updated
    February 21, 2017
    Sponsor
    H. Lee Moffitt Cancer Center and Research Institute
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01302821
    Brief Title
    C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer
    Official Title
    NCI 8701: A Pilot Study Utilizing C11 Alpha Methyl Tryptophan (AMT) PET Functional Imaging in Patients With Metastatic Invasive Breast Cancer Treated With 1 Methyl D Tryptophan Plus the Ad p53 DC Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2013 (Anticipated)
    Primary Completion Date
    December 2014 (Anticipated)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    H. Lee Moffitt Cancer Center and Research Institute
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this research project is to create images of where and how the amino acid (the building blocks of proteins)Tryptophan is processed in normal and abnormal tissue in the patient's body. Tryptophan is a normal building block of proteins in the body. Sometimes in the case of cancer and other diseases, Tryptophan is processed abnormally, and possible treatments for this abnormality are of great interest because of the potential to improve cancer care.
    Detailed Description
    Coordinating Center: Southeast Phase 2 Consortium (SEP2C), Moffitt Cancer Center. Research participation involves up to three experimental imaging examination visits in radiology: a baseline before the patient starts a cancer treatment, a follow-up a few days later, and a later follow up to see how the treatment may affect normal or abnormal processing of Tryptophan. The research imaging results will be linked with other evidence of the patient's disease, but will not effect their care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    breast - male, breast - female, metastatic, invasive

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiotherapy
    Arm Type
    Experimental
    Arm Description
    AMT positron emission tomography with integrated computed tomography (PET/CT)scanning in metastatic breast cancer patients to identify tumors with increased AMT uptake due to up-regulated IDO expression.
    Intervention Type
    Biological
    Intervention Name(s)
    Adenovirus-p53 transduced dendritic cell vaccine
    Other Intervention Name(s)
    Ad.p53 DC, vaccine, Advexin
    Intervention Description
    The Ad.p53 DC vaccine will be injected intradermally (through the skin) into four separate sites. The patient's vaccine will be the same dose throughout the study.
    Intervention Type
    Drug
    Intervention Name(s)
    1-methyl-D-tryptophan
    Other Intervention Name(s)
    NSC 721782, 1-MT
    Intervention Description
    Each treatment cycle is comprised of 21 days. The treatment is continuous with no breaks in between cycles. Patients would not be allowed to take any tryptophan containing supplements while participating on this study.
    Intervention Type
    Radiation
    Intervention Name(s)
    Carbon C 11 alpha-methyltryptophan
    Other Intervention Name(s)
    radioactive tracer
    Intervention Description
    The experimental examination for this research is the administration by a needle in a vein of Tryptophan labeled with a radioactive tracer (a substance is believed to enhance imaging for easier detection and measurement), Carbon 11, when when the patient has not eaten for five hours. A standard PET/CT scanner is then used to create images of the tracer a few minutes later.
    Primary Outcome Measure Information:
    Title
    Occurrence of Detected Changes in Regions of Interest (ROIs)
    Description
    Changes in C-11 AMT uptake and localization (measured by SUV) between baseline and approximately 4 days after initiation of treatment. The primary objective is to determine whether such changes can be detected in regions of interest (ROIs) using PET/CT imaging in patients with metastatic breast cancer enrolled in NCI 8461/ MCC16025. The SUV values in identified regions of interest (ROIs) for each patient will be compared over time between baseline and approximately 4 days after initiation of treatment, and after completion of the protocol treatment. The analysis will be largely exploratory and descriptive as the sample size and study design will likely preclude an adequate/definitive statistical conclusion of SUV values between the two time points.
    Time Frame
    Average of 7 weeks
    Secondary Outcome Measure Information:
    Title
    Number of Participants with Clinical Response
    Description
    Clinical responses based on Response Evaluation Criteria In Solid Tumors [RECIST] criteria, to 1-MT plus the Ad.p53 DC vaccine.
    Time Frame
    Average of 7 weeks
    Title
    Number of Participants with Presence of IDO ImmunoHistoChemistry (IHC) Expression
    Description
    Presence of immuno-modulatory enzyme indoleamine 2,3-dioxygenase (IDO) IHC expression (positive vs. negative as described in NCI 8461/MCC 16025) in the assayed tumor sample.
    Time Frame
    Average of 7 weeks
    Title
    Number of Participants with Immune Response
    Description
    Immune response to the vaccine (by ELISPOT criteria as described in NCI 8461/MCC 16025). The secondary endpoint immunologic response is defined as IFN-γ p53 T cell specific ELISPOT assay count measured, being ≥ 2 SDs above the baseline for a patient.
    Time Frame
    Average of 7 weeks
    Title
    Number of Participants with Adverse Events
    Description
    Examine toxicity data of the protocol treatment according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
    Time Frame
    Average of 7 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must be enrolled on the NCI 8461/MCC 16025 study. Consent for participation in this companion imaging study and be able to successfully complete a minimum of two AMT PET/CT scans. Exclusion Criteria: Patients must not meet any of the exclusion criteria for the NCI 8461/ MCC 16025 study. Not have any medical conditions prohibiting the successful completion of a minimum of two AMT PET/CT scans.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hatem Soliman, M.D.
    Organizational Affiliation
    H. Lee Moffitt Cancer Center and Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer

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