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

Sponsor

City of Hope Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01741597

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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.
To evaluate the pharmacokinetics of iRGD. III. To explore the safety of iRGD.

SECONDARY OBJECTIVES:

To explore changes in water diffusion status in tumors due to iRGD as measured by diffusion-weighted (DWI) MRI.
To explore the ability of iRGD to elicit changes in primary pancreatic cancer vascular permeability as measured by dynamic contrast enhanced (DCE) MRI.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2016

Arms and Interventions

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 Names: DCE-MRI Other: pharmacological study Correlative studies Other Names: pharmacological studies Biological: tumor-homing peptide iRGD Undergo tumor-homing peptide iRGD DCE-MRI Other Names: iRGD

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 Names:

DCE-MRI

Other: pharmacological study

Correlative studies

Other Names:

pharmacological studies

Biological: tumor-homing peptide iRGD

Undergo tumor-homing peptide iRGD DCE-MRI

Other Names:

iRGD

Outcome Measures

Primary Outcome Measures

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 [Baseline to 15 days]
Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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