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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741597
Recruitment Status : Withdrawn (PI chose to close the study)
First Posted : December 5, 2012
Last Update Posted : May 30, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date May 30, 2014
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
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 [ Time Frame: Baseline to 15 days ]
Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
The potential for tumor-homing peptide iRGD to enhance uptake of key anti-cancer agents [ Time Frame: Up to 15 days ]
Analyzed using a multi-compartment pharmacokinetic modeling algorithm already implemented at multiple clinical trial sites for breast and body imaging.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dynamic Contrast Enhanced MRI in Patients With Advanced Breast or Pancreatic Cancer With Metastases to the Liver or Lung
Official Title  ICMJE A First Time in Human Phase I Imaging Study of iRGD in Patients With Advanced Breast and Pancreas Cancer
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
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
    Undergo DCE-MRI
    Other Name: DCE-MRI
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
  • Biological: tumor-homing peptide iRGD
    Undergo tumor-homing peptide iRGD DCE-MRI
    Other Name: iRGD
Study Arms  ICMJE 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.
Interventions:
  • Procedure: dynamic contrast-enhanced magnetic resonance imaging
  • Other: pharmacological study
  • Biological: tumor-homing peptide iRGD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2012)
27
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741597
Other Study ID Numbers  ICMJE 12228
NCI-2012-02449 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P01CA043904 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Vincent Chung City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP