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

This study has been withdrawn prior to enrollment.
Sponsor:
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: March 18, 2014
Last verified: March 2014
  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:


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.


Enrollment: 0
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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:
  • Ad.p53 DC
  • vaccine
  • Advexin
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:
  • NSC 721782
  • 1-MT
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

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: March 18, 2014
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 April 15, 2014