Breast Cancer
Conditions
Keywords
breast - male, breast - female, metastatic, invasive
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.
Interventions
BIOLOGICALAdenovirus-p53 transduced dendritic cell vaccine
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.
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.
RADIATIONCarbon C 11 alpha-methyltryptophan
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.
Sponsors
National Cancer Institute (NCI)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Detected Changes in Regions of Interest (ROIs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Clinical Response | 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. |
| Number of Participants with Presence of IDO ImmunoHistoChemistry (IHC) Expression | 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. |
| Number of Participants with Immune Response | 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. |
| Number of Participants with Adverse Events | Average of 7 weeks | Examine toxicity data of the protocol treatment according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0. |
Outcome results
None listed