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

City of Hope

Status and phase

Withdrawn

Phase 1

Conditions

Liver Metastases

Stage IV Pancreatic Cancer

Duct Cell Adenocarcinoma of the Pancreas

Recurrent Pancreatic Cancer

Recurrent Breast Cancer

Acinar Cell Adenocarcinoma of the Pancreas

Stage IV Breast Cancer

Lung Metastases

Treatments

Biological: tumor-homing peptide iRGD

Other: pharmacological study

Procedure: dynamic contrast-enhanced magnetic resonance imaging

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01741597

P01CA043904 (U.S. NIH Grant/Contract)

12228 (Other Identifier)

NCI-2012-02449 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No 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