Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

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

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

40um Embozene TANDEM Microspheres

Franco Orsi, MD

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).

Colon or rectal carcinoma that has spread to the liver is considered to be metastatic and is a Stage IV cancer. If the metastasized tumor is unresectable, the only current treatment is chemotherapy. Transarterial Chemoembolization (TACE) is considered as a palliative treatment in advanced metastatic colorectal carcinoma (mCRC), with the potential of local tumor control. TACE has evolved in the past 8 years to include drug-delivery devices that can target and deliver drugs from small microparticles (DEB-TACE). Superselective DEB-TACE has the potential to penetrate deeper into the tumor's vasculature to reach peripheral growing points. Loading these microparticles with a cytotoxic drug may improve the level of local tumor control.

The MIRACLE III study is a controlled, pilot, single center (Italy) study on 18 subjects with pretreated non-resectable mCRC.

Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy

Microparticle Enhanced Cytotoxic Transarterial Embolization Therapy: A Pilot Study of Irinotecan in the Treatment of Metastatic Colorectal Carcinoma (mCRC) by Embozene TANDEM™ Drug-Eluting Microspheres Embolization

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.

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).

Number of participants that were alive 12 months after their first study treatment.

Time to Tumor Progression is defined as the time from the date of first study treatment to the day of documented disease progression or death due to any cause, whichever came first, assessed up to 1 year. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Boston Scientific Corporation

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

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

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Italy

Region of Enrollment

ECOG 0 - Fully active, able to carry out all pre-disease performance without restriction. ECOG 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work. ECOG 2 - Ambulatory and capable of all self care, but unable to carry out any work activities. Up and about more than 50% of waking hours. ECOG 3 - Capable of only limited self care, confined to bed or chair more than 50% of waking hours. ECOG 4 - Completed disabled. Cannot carry out any self care. Totally confined to bed or chair. ECOG 5 -Dead

Eastern Cooperative Oncology Group (ECOG) Performance Score

TNM staging takes into account the size of the tumour, whether the lymph nodes (glands) are affected and whether cancer cells have spread anywhere else.

TNM stands for Tumour, Node, Metastasis. The TNM system describes the size of a primary tumour (T), whether the cancer has spread to the lymph nodes (N), and whether the cancer has spread to a different part of the body (M - for metastases).

Classification of Malignant Tumours (TNM) Stage

The Pugh-Child score is measured utilizing five clinical measures. The five measures are: total bilirubin (yellow compound in bile from hemoglobin breakdown), serum albumin (blood protein produced in the liver), prothrombin time (time for blood to clot), ascites (fluid in peritoneal cavity), and hepatic encephalopathy (brain disorder from liver disease). A score of 1, 2, or 3 is given to each measure, with 3 being the most severe.

From these assessments, Child-Pugh is scored as follows: Class A (5 to 6 points), Class B (7 to 9 points), and Class C (10 to 15 points)

Child Pugh

History of Radiotherapy

History of Surgical Therapy

History of Systemic Therapy

Previous Lines of Chemotherapy

A total of 20 patients were consented to participate however, 2 patients were not enrolled as they were reported as screen failures prior to the first study treatment. Therefore a total of 18 baseline patients were assessed.

Angela Schutt

Freedom From Serious Adverse Events Rate

All subjects were included in this analysis except for one subject that was removed from the study after undergoing liver resection surgery.

Local Tumor Control

Survival Rate

Two participants that did not have disease progression reported during the trial are not included in this analysis. One subject underwent liver resection surgery after their third study treatment and another subject's tumor response was reported as stable disease prior to being lost to follow up after their third study treatment.

Spots Global Cancer Trial Database for 40um embozene tandem microspheres