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

Withdrawn before enrolling · Phase 1

Conditions studied: 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

In brief

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

Key facts

Study ID: NCT01741597
Run by: City of Hope Medical Center
People needed: 0
Starts: 2014-07-01
Last updated by the study team: 2014-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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