Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy

NCT02694562 | Completed Results

• 1 other identifier: MIRACLE III
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine safety and local tumor control of Embozene TANDEM Microspheres (40um TANDEM) loaded with Irinotecan to treat metastatic colorectal carcinoma (mCRC).

Conditions

Colorectal Carcinoma

Keywords

Metastatic Colorectal Carcinoma

Outcome Measures

Primary Outcomes (4)

• Freedom From Serious Adverse Events Rate

  Freedom from Serious Adverse Events reports the number of participants that did not have a serious adverse event reported within 30 days of treatment that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defects.

  30 days

• Local Tumor Control

  Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).

  3 months post procedure

• Local Tumor Control

  Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).

  6 months post procedure

• Local Tumor Control

  Local tumor control reports the percent of subjects for which the size of the tumor does not increase. Local Tumor Control is defined as subjects having complete response or stable disease. For these subjects the treated tumor either shrinks or stays the same size when measuring the tumor using a standard tumor measurement guideline (based on the devascularization pattern from the European Association for the Study of the Liver (EASL) criteria).

  12 months post procedure

Secondary Outcomes (2)

• Survival Rate

  12 months post procedure

• Time To Tumor Progression

  Up to 12 months post procedure

Study Arms (1)

40um Embozene TANDEM Microspheres

EXPERIMENTAL

40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg)

Device: 40um Embozene TANDEM Microspheres

Interventions

40um Embozene TANDEM Microspheres DEVICE

40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).

40um Embozene TANDEM Microspheres

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, age \>18 yrs who have histologically confirmed adenocarcinoma of the colon or rectum (Stage IV)
• Presence of metastatic disease with liver as dominant disease-site defined as \>80% tumor body burden confined to liver; less than 60% liver tumor replacement.
• Subject is competent and willing to provide written informed consent in order to participate in the study.
• Eastern Cooperative Oncology Group (ECOG) performance status is 0-1 or Child-Pugh classification is A or B7.
• Multinodular or single nodular tumor 4 cm, patients with bilobar disease who can be treated superselectively in a single session or both lobes able to be treated within 3 weeks. Patient must have at least one tumor lesion that meets the following criteria: lesion can be accurately measured in at least one dimension according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.
• Pretreatment with two or more lines of chemotherapy containing Fluorouracil (5-FU) or analogue, oxaliplatin, irinotecan ± bevacizumab ±epidermal growth factor receptor (EGFR)-inhibitors, if indicated, for metastatic disease.
• No invasion in the blood vessel (hepatic portal, hepatic vein) or bile duct by the computerized axial tomography (CT) or Magnetic Resonance (MR) Imaging.
• Proper blood, liver, renal, heart function: testing result within 2 weeks from registry of this study as follows:
• White Blood Cell (WBC) \>3,000 cells/mm3
• Absolute neutrophil count ≥1500/mm3
• International Normalized Ratio (INR) \<2.0
• Partial Thromboplastin Time (PTT) \<40 sec
• Platelet count \>50,000/mm3
• Blood bilirubin \<3.0 mg/dL
• Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) is within 5 times of normal range of each organ

You may not qualify if:

• ECOG performance status \>2; or Child-Pugh class\>11 points or more, or American Society of Anaesthesiologists' (ASA) class 5 .
• Bilirubin levels \>3 mg/dL
• mCRC within the large vessel or biliary duct invasion, diffuse hepatocellular carcinoma (HCC) or extrahepatic spread.
• Patients in which any of the following are contraindicated or present:
• The use of irinotecan
• MRI or CT scans
• Hepatic embolization procedures
• WBC \<3000 cells/mm3
• neutrophil \<1500 cells/mm3
• Cardiac ejection fraction \<50% assessed by isotopic ventriculography, echocardiography or MRI
• Elevated serum creatinine ≥ 2.5 mg/dL
• Impaired clotting test (platelet count \< 50,000/mm3, PT-INR \>2.0
• AST and/or ALT \>5x upper limit of normal (ULN), when greater \>250 U/I
• Known hepatofugal blood flow.
• Arterio-venous shunt

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Angela Schutt
• Organization: Boston Scientific

angela.schutt@bsci.com

763-494-2166

Study Officials

• Franco Orsi, MD

  European Institute of Oncology (Milan Italy)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: February 29, 2016
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)