Breast CancerNCT01302821
C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer
A study testing Adenovirus-p53 transduced dendritic cell vaccine, 1-methyl-D-tryptophan and Carbon C 11 alpha-methyltryptophan in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Adenovirus-p53 transduced dendritic cell vaccine, 1-methyl-D-tryptophan and Carbon C 11 alpha-methyltryptophan
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Adenovirus-p53 transduced dendritic cell vaccine, 1-methyl-D-tryptophan, Carbon C 11 alpha-methyltryptophan
- Keywords
- breast - male, breast - female, metastatic, invasive
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenovirus-p53 transduced dendritic cell vaccineBiological
Also called Ad.p53 DC, vaccine, Advexin
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.
1-methyl-D-tryptophanDrug
Also called NSC 721782, 1-MT
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.
Carbon C 11 alpha-methyltryptophanRadiation
Also called radioactive tracer
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | 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. Receives: Biological: Adenovirus-p53 transduced dendritic cell vaccine; Drug: 1-methyl-D-tryptophan; Radiation: Carbon C 11 alpha-methyltryptophan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Average of 7 weeks
Secondary outcomes (4)
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.
Measured: Average of 7 weeks
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.
Measured: Average of 7 weeks
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.
Measured: Average of 7 weeks
Number of Participants with Adverse Events
Examine toxicity data of the protocol treatment according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0.
Measured: Average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startJan 2013 (estimated)
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Hatem Soliman, M.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302821
- Sponsor's protocol ID
- NCI 8701
- Other IDs
- MCC-16216
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01302821
- Acronym / sponsor ID
- NCI 8701
- Conditions
- Breast Cancer
- Keywords
- breast - male, breast - female, metastatic, invasive
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2013 (estimated)
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Biological: Adenovirus-p53 transduced dendritic cell vaccine, Drug: 1-methyl-D-tryptophan, Radiation: Carbon C 11 alpha-methyltryptophanAMT 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adenovirus-p53 transduced dendritic cell vaccineAlso: Ad.p53 DC, vaccine, AdvexinThe 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. | Biological | Radiotherapy |
| 1-methyl-D-tryptophanAlso: NSC 721782, 1-MTEach 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. | Drug | Radiotherapy |
| Carbon C 11 alpha-methyltryptophanAlso: radioactive tracerThe 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. | Radiation | Radiotherapy |
Primary outcome
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.
4 secondary outcomes
Number of Participants with Clinical Response
Time frame: Average of 7 weeks
Number of Participants with Presence of IDO ImmunoHistoChemistry (IHC) Expression
Time frame: Average of 7 weeks
Number of Participants with Immune Response
Time frame: Average of 7 weeks
Number of Participants with Adverse Events
Time frame: Average of 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hatem Soliman, M.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Adenovirus-p53 transduced dendritic cell vaccine, 1-methyl-D-tryptophan and Carbon C 11 alpha-methyltryptophan in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Detected Changes in Regions of Interest (ROIs) (time frame: Average of 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.