This clinical trial is designed to evaluate the effectiveness and collect additional safety information on Ultratrace® Iobenguane I 131 for the treatment of relapsed/refractory (to other treatment) malignant pheochromocytoma and paraganglioma. The purpose of this trial is to test the use of Ultratrace® iobenguane I 131 as a treatment for pheochromocytoma and paraganglioma type cancer. This Phase II study will help determine primarily if using the drug reduces the amount of blood pressure medication being taken as a result of the cancer and secondarily to determine such things as the effectiveness of the study drug in treating the cancer, additional safety measures, and to assess if the drug helps the quality of life and use of pain medication. All subjects will receive an imaging dose with scans followed by two therapy doses that are given 3 months apart.
A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Azedra™ Ultratrace® (Iobenguane I 131), commonly referred to as Ultratrace Iobenguane I 131, is a very high specific activity form of iobenguane I 131, produced using Molecular Insight's proprietary Ultratrace® platform. Based on the well characterized cellular active transport mechanism, the higher the specific activity of iobenguane I 131, the greater the cellular uptake of radioactivity and hence greater tumor uptake.
During this study the subjects will receive two (2) Therapy Doses that are given three (3) months apart. Prior to administration of the first Therapy Dose, subjects will be given an Imaging Dose of Ultratrace Iobenguane I 131 and will undergo iobenguane I 131 scans to evaluate tumor uptake and to measure normal organ distribution and allow for the calculation of radiation dose to normal organs.
Screening procedures for eligibility will need to be done before imaging or therapeutic doses of Iobenguane I 131 are administered.
Hospitalization is required for approximately one (1) week after each of the two (2) Therapeutic Doses. Frequent follow up is necessary for the first year and some of the follow up visits may be done by a visiting health care professional in the subjects' homes. Subjects will be followed in the treatment study for one (1) year and for an additional four (4) years in long-term follow up.
Pheochromocytoma Paraganglioma radiotherapy MIBG Azedra neuroendocrine tumors Iobenguane I 131 progenics 3-Iodobenzylguanidine
Open to people ages 12 years and up
Subjects will be excluded if any of the following conditions are observed:
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