NCT01302821

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

February 22, 2011

Last Update Submit

February 21, 2017

Conditions

Breast Cancer

Keywords

breast - malebreast - femalemetastaticinvasive

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of Participants with Clinical Response

    Average of 7 weeks

  • Number of Participants with Presence of IDO ImmunoHistoChemistry (IHC) Expression

    Average of 7 weeks

  • Number of Participants with Immune Response

    Average of 7 weeks

  • Number of Participants with Adverse Events

    Average of 7 weeks

Study Arms (1)

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.

Biological: Adenovirus-p53 transduced dendritic cell vaccineDrug: 1-methyl-D-tryptophanRadiation: Carbon C 11 alpha-methyltryptophan

Interventions

Adenovirus-p53 transduced dendritic cell vaccineBIOLOGICAL

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.

Also known as: Ad.p53 DC, vaccine, Advexin
Radiotherapy
1-methyl-D-tryptophanDRUG

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.

Also known as: NSC 721782, 1-MT
Radiotherapy
Carbon C 11 alpha-methyltryptophanRADIATION

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.

Also known as: radioactive tracer
Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not have any medical conditions prohibiting the successful completion of a minimum of two AMT PET/CT scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Vaccinesadvexin1-methyltryptophanalpha-methyltryptophanRadioactive Tracers

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological ProductsComplex MixturesRadioisotopesIsotopesInorganic ChemicalsIndicators and ReagentsLaboratory ChemicalsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Hatem Soliman, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 24, 2011

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 23, 2017

Record last verified: 2017-02