Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver
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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 . |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| 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:
|
Breast Neoplasms Neoplasms Colorectal Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Liver Neoplasms Lung Neoplasms Stomach Neoplasms Melanoma Neoplasm Metastasis Pancreatic Neoplasms Cholangiocarcinoma Sarcoma |
Neoplasms by Site Breast Diseases Skin Diseases Intestinal Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Head and Neck Neoplasms Liver Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013