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Sponsored by: |
FeRx |
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Information provided by: | FeRx |
ClinicalTrials.gov Identifier: | NCT00041808 |
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 I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 . |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, California | |
UCSF Cancer Center | |
San Francisco, California, United States, 94143 | |
Scripps Stevens Cancer Division | |
San Diego, California, United States, 92037 | |
United States, Texas | |
Scott and White Clinic | |
Temple, Texas, United States, 76508 | |
Germany | |
Frankfurt Universtiy | |
Frankfurt, Germany, 60590 |
Study Chair: | Joy Koda, PhD |
Study ID Numbers: | MTC-DOX-003 |
Study First Received: | July 17, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00041808 History of Changes |
Health Authority: | United States: Food and Drug Administration |
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 |
Thoracic Neoplasms Liver Diseases Pancreatic Neoplasms Colonic Diseases Rectal Diseases Neoplasms, Connective and Soft Tissue Lung Neoplasms Neoplasm Metastasis Neuroepithelioma Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Breast Neoplasms Endocrine System Diseases Esophageal Cancer |
Doxorubicin Carcinoma Neuroectodermal Tumors Malignant Mesenchymal Tumor Esophageal Disorder Lung Diseases Sarcoma Gastrointestinal Neoplasms Pancreatic Diseases Esophageal Diseases Nevus Stomach Cancer Neoplasms, Glandular and Epithelial Gastrointestinal Diseases Esophageal Neoplasms |
Thoracic Neoplasms Liver Diseases Pancreatic Neoplasms Colonic Diseases Rectal Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Site Pathologic Processes Lung Neoplasms Therapeutic Uses Neoplasm Metastasis Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Breast Neoplasms |
Endocrine System Diseases Doxorubicin Carcinoma Neuroectodermal Tumors Neoplasms Lung Diseases Sarcoma Gastrointestinal Neoplasms Pancreatic Diseases Esophageal Diseases Neoplasms, Glandular and Epithelial Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Neoplasms, Nerve Tissue |