Dynamic Contrast Enhanced MRI In Patients With Advanced Breast Or Pancreatic Cancer With Metastases To The Liver Or Lung

Study Overview

Dynamic Contrast Enhanced MRI in Patients With Advanced Breast or Pancreatic Cancer With Metastases to the Liver or Lung

This phase I trial studies the side effects of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) in patients with advanced breast or pancreatic cancer with metastases to the liver or lung. Diagnostic procedures, such as DCE-MRI, may help measure a patient's response to treatment

PRIMARY OBJECTIVES: I. To explore the ability of iRGD (tumor-homing peptide iRGD) to elicit changes in metastatic breast cancer vascular permeability as measured by dynamic contrast enhanced (DCE) MRI. II. To evaluate the pharmacokinetics of iRGD. III. To explore the safety of iRGD. SECONDARY OBJECTIVES: I. To explore changes in water diffusion status in tumors due to iRGD as measured by diffusion-weighted (DWI) MRI. II. To explore the ability of iRGD to elicit changes in primary pancreatic cancer vascular permeability as measured by dynamic contrast enhanced (DCE) MRI. III. To explore changes in water diffusion status in primary pancreatic cancer due to iRGD as measured by DWI-MRI. OUTLINE: Patients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2. After completion of study treatment, patients are followed up for 15 days.

Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Liver Metastases
Lung Metastases
Recurrent Breast Cancer
Recurrent Pancreatic Cancer
Stage IV Breast Cancer
Stage IV Pancreatic Cancer

PROCEDURE: dynamic contrast-enhanced magnetic resonance imaging
OTHER: pharmacological study
BIOLOGICAL: tumor-homing peptide iRGD

12228
NCI-2012-02449 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
P01CA043904 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-12-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-05-28
First Submitted that Met QC Criteria 2012-12-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-05-30
First Posted (ESTIMATED) 2012-12-05	Results First Posted N/A	Last Verified 2014-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Diagnostic (DCE-MRI, tumor-homing peptide iRGD) Patients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2.	PROCEDURE: dynamic contrast-enhanced magnetic resonance imaging Undergo DCE-MRI OTHER: pharmacological study Correlative studies BIOLOGICAL: tumor-homing peptide iRGD Undergo tumor-homing peptide iRGD DCE-MRI

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Diagnostic (DCE-MRI, tumor-homing peptide iRGD)

Patients undergo DCE-MRI on day 1 and undergo tumor-homing peptide iRGD DCE-MRI on day 2.

PROCEDURE: dynamic contrast-enhanced magnetic resonance imaging

Undergo DCE-MRI

OTHER: pharmacological study

Correlative studies

BIOLOGICAL: tumor-homing peptide iRGD

Undergo tumor-homing peptide iRGD DCE-MRI

Primary Outcome Measures	Measure Description	Time Frame
Change in volume transfer coefficient (Ktrans) during DCE-MRI with tumor-homing peptide iRGD compared to a baseline DCE-MRI without tumor-homing peptide iRGD	Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.	Baseline to 15 days

Secondary Outcome Measures	Measure Description	Time Frame
The potential for tumor-homing peptide iRGD to enhance uptake of key anti-cancer agents	Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.	Up to 15 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patient must have a histologic diagnosis of breast or pancreatic adenocarcinoma (expansion cohort) metastatic to the liver or lung
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Women of child-bearing potential must have a negative serum pregnancy test within 7 days of the first DCE-MRI and must have agreed to use an effective contraceptive method; the effects of iRGD on the developing fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
Patient must have a measurable lesion at least 2 cm in size amenable to DCE-MRI study as determined by Radiology
Computed tomography (CT)/MRI scan must be obtained within 3 weeks prior to study entry
Absolute neutrophil count >= 1,500/mcl
Platelet count >= 100,000/mcl
Creatinine =< 1.3 mg/dl or a measured creatinine clearance >= 60 cc/min
Bilirubin =< 1.5 mg/dl
Alanine aminotransferase (ALT), aspartate aminotransferase (AST) no greater than 2.5 times the upper limit of normal for patients with liver metastases; patients without liver metastasis should have ALT and AST no greater than 1.5 times the upper limit of normal
Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator
All subjects must have the ability to understand and the willingness to sign a written informed consent
Patients with grade 2 or higher toxicity due to previous chemotherapy; all toxicities should recover to grade 0 or 1 prior to day 1

Patients experiencing an infusion reaction with the day 1 DCE-MRI
Patients with any grade electrolyte abnormalities that are unable to be corrected by day 1
Patients with a history of previous reaction to IV contrast
Impaired cardiac function including any one of the following:

Complete left bundle branch block or use of a permanent cardiac pacemaker
Congenital long QT syndrome
Presence of ventricular tachyarrhythmias
Clinically significant resting bradycardia (< 50 beats per minute)
Corrected Fridericia's QT interval (QTcF) > 450 msec on screening electrocardiogram (ECG)
Right bundle branch block + left anterior hemiblock (bifascicular block)
Presence of atrial fibrillation
Previous history angina pectoris or acute myocardial infarction (MI) within 6 months
Congestive heart failure (New York Heart Association functional classification III-IV)
Uncontrolled hypertension (mmHg > 140 systolic or > 90 diastolic)
Brain or leptomeningeal metastases
Patients with an active, bleeding diathesis or requiring therapeutic anticoagulation
Patients receiving bevacizumab within 3 months of study entry
Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
Patients should not have any uncontrolled illness including ongoing or active infection
Patients may not be receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to iRGD
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

PRINCIPAL_INVESTIGATOR: Vincent Chung, City of Hope Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record