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

Primary Purpose

Metastases, Neoplasm, Colorectal Neoplasms, Esophageal Neoplasms

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MTC-DOX for Injection
Chemotherapy
Sponsored by
FeRx
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastases, Neoplasm focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scripps Stevens Cancer Division
  • UCSF Cancer Center
  • Scott and White Clinic
  • Frankfurt Universtiy

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 17, 2002
Last Updated
June 23, 2005
Sponsor
FeRx
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1. Study Identification

Unique Protocol Identification Number
NCT00041808
Brief Title
Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver
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 .
Study Type
Interventional

2. Study Status

Record Verification Date
February 2003
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
FeRx

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastases, Neoplasm, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Breast Neoplasms, Melanoma, Sarcoma, Gastrointestinal Neoplasms, Lung Neoplasms, Liver Neoplasms, Cholangiocarcinoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
MTC-DOX for Injection
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Koda, PhD
Official's Role
Study Chair
Facility Information:
Facility Name
Scripps Stevens Cancer Division
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCSF Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Scott and White Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Frankfurt Universtiy
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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