- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302821
C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer
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 Overview
Status
Conditions
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Radiotherapy
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.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Detected Changes in Regions of Interest (ROIs)
Time Frame: Average of 7 weeks
|
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.
|
Average of 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Clinical Response
Time Frame: Average of 7 weeks
|
Clinical responses based on Response Evaluation Criteria In Solid Tumors [RECIST] criteria, to 1-MT plus the Ad.p53 DC vaccine.
|
Average of 7 weeks
|
Number of Participants with Presence of IDO ImmunoHistoChemistry (IHC) Expression
Time Frame: Average of 7 weeks
|
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.
|
Average of 7 weeks
|
Number of Participants with Immune Response
Time Frame: Average of 7 weeks
|
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.
|
Average of 7 weeks
|
Number of Participants with Adverse Events
Time Frame: Average of 7 weeks
|
Examine toxicity data of the protocol treatment according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
|
Average of 7 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI 8701
- MCC-16216 (OTHER: H. Lee Moffitt Cancer Center and Research Institute)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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