Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver

MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.

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Key information

Conditions

Metastases, Neoplasm Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Cholangiocarcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Frankfurt Universtiy, Frankfurt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a Karnofsky (or equivalent) performance status > 60 and an expected survival of > 2 months
Patients agreeing to use a medically effective method of contraception
Patients able to understand and give written informed consent
The center of the tumor mass must be < or = 14 cm from the anterior or lateral abdominal wall as determined by cross sectional imaging measured at baseline. This is required for optimal retention of MTC-DOX by the magnetic field. If more than one tumor mass is present, all of the treated tumor masses must meet this criterion

Exclusion criteria

Women who are pregnant or lactating
Patient's with metastatic liver cancer, or other primary liver cancer excluding HCC, with diffuse disease that does not have focal area(s) conducive to local regional therapy
Patients with the following laboratory abnormalities:Hemoglobin < 10.0 g/dL;Granulocyte count < 1,500 per mm3;Platelet count < 50,000 per mm3; Lymphocyte count < 0.5 x 10 to the 9th per L; Total bilirubin >/= 3.0 mg/dL;AST or ALT >/= 5x the upper limit of normal;INR >/= 1.3; Creatinine >/= 2.0 mg/dL
Patients with either significant cardiovascular disease or any other organ system dysfunction which, in the opinion of the investigator, would either compromise the patient's safety or interfere with the evaluation of the test material. Patients with evidence of a myocardial infarction within six (6) months prior to this trial will be excluded.
Patients with an indwelling cardiac pacemaker, cerebral aneurysm clips, or any other indwelling device or appliance that could be adversely affected by the use of the external magnet
Patients at the time of study entry with a second invasive cancer other than basal cell and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
Patients with documented evidence of hemachromatosis or hemosiderosis
Patients with CT or ultrasound evidence of portal vein invasion or thrombosis
Patients who have had prior anthracycline therapy with a left ventricular ejection fraction (LVEF) <50%, as measured by either multigated radionuclide angiography (MUGA) scan or echocardiogram.

Treatment and study plan

MTC-DOX for Injection

Drug

Chemotherapy

Procedure

Sponsors and collaborators

Lead sponsor

FeRx

Industry

Registry information

Official study title

A Phase I/II Single Dose Trial to Determine The Safety, Tolerance, Pharmacokinetic Profile, and Preliminary Activity of Intrahepatic Delivery (Via Hepatic Artery Catheterization) of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers ( MTC-DOX) in Patients With Metastatic Cancer to the Liver .

Important dates

Study start: 2001
Study completion: 2003
First posted: Jul 19, 2002
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed