C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer
This study is not yet open for participant recruitment.
Verified April 2013 by H. Lee Moffitt Cancer Center and Research Institute
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01302821
First received: February 22, 2011
Last updated: April 26, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Biological: Adenovirus-p53 transduced dendritic cell vaccine Drug: 1-methyl-D-tryptophan Radiation: Carbon C 11 alpha-methyltryptophan |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Tryptophan
U.S. FDA Resources
Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:
Primary Outcome Measures:
- Occurrence of Detected Changes in Regions of Interest (ROIs) [ Time Frame: Average of 7 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Average of 7 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Average of 7 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Average of 7 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Average of 7 weeks ] [ Designated as safety issue: Yes ]Examine toxicity data of the protocol treatment according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Biological: Adenovirus-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.
Other Names:
Drug: 1-methyl-D-tryptophan
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:
Radiation: Carbon 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.
Other Name: radioactive tracer
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302821
Locations
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Melissa Cochran 813-745-2836 melissa.cochran@moffitt.org | |
| Principal Investigator: Hatem Soliman, M.D. | |
| Sub-Investigator: Scott Antonia, M.D., Ph.D. | |
| Sub-Investigator: Robert Gillies, Ph.D. | |
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
| Principal Investigator: | Hatem Soliman, M.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01302821 History of Changes |
| Other Study ID Numbers: | NCI 8701, MCC-16216 |
| Study First Received: | February 22, 2011 |
| Last Updated: | April 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
breast - male breast - female metastatic invasive |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tryptophan |
Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013