C11 AMT Positron Emission Tomography (PET) Imaging in Patients With Metastatic Invasive Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01302821
• Other study ID #: NCI 8701
• Secondary ID: MCC-16216
• Status: Withdrawn
• Phase: N/A
• First received: February 22, 2011
• Last updated: February 21, 2017
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2017
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Average of 7 weeks
Secondary	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.	Average of 7 weeks
Secondary	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.	Average of 7 weeks
Secondary	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-? p53 T cell specific ELISPOT assay count measured, being = 2 SDs above the baseline for a patient.	Average of 7 weeks
Secondary	Number of Participants with Adverse Events	Examine toxicity data of the protocol treatment according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0.	Average of 7 weeks