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Withdrawn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
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring breast - male, breast - female, metastatic, invasive
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.
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
NCT ID
NCT01302821
First Posted
February 22, 2011
Last Updated
February 21, 2017
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
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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