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

This study has been completed.
Sponsor:
Information provided by:
FeRx
ClinicalTrials.gov Identifier:
NCT00041808
First received: July 17, 2002
Last updated: June 23, 2005
Last verified: February 2003
  Purpose

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.


Condition Intervention Phase
Metastases, Neoplasm
Colorectal Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Breast Neoplasms
Melanoma
Sarcoma
Gastrointestinal Neoplasms
Lung Neoplasms
Liver Neoplasms
Cholangiocarcinoma
Drug: MTC-DOX for Injection
Procedure: Chemotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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 .

Resource links provided by NLM:


Further study details as provided by FeRx:

Estimated Enrollment: 20
Study Start Date: July 2001
Estimated Study Completion Date: April 2003
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041808

Locations
United States, California
Scripps Stevens Cancer Division
San Diego, California, United States, 92037
UCSF Cancer Center
San Francisco, California, United States, 94143
United States, Texas
Scott and White Clinic
Temple, Texas, United States, 76508
Germany
Frankfurt Universtiy
Frankfurt, Germany, 60590
Sponsors and Collaborators
FeRx
Investigators
Study Chair: Joy Koda, PhD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00041808     History of Changes
Obsolete Identifiers: NCT00023803
Other Study ID Numbers: MTC-DOX-003
Study First Received: July 17, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by FeRx:
Metastatic liver cancer
Cholangiocarcinoma
colorectal cancer
esophageal cancer
gastric cancer
pancreatic cancer
breast cancer
malignant melanoma
sarcoma
GIST
gastrointestinal stromal tumor
lung cancer
liver cancer

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Melanoma
Breast Neoplasms
Cholangiocarcinoma
Colorectal Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Liver Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasm Metastasis
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014