Clinical Trial: A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Molecular Insight Pharmaceuticals, Inc.

Current Primary Outcome: Proportion of study subjects with a reduction (including discontinuation) of all antihypertensive medication by at least 50% for at least six months or two cycles of Ultratrace Iobenguane I 131. [ Time Frame: 12 Months ]

Original Primary Outcome: Proportion of study subjects with a reduction (including discontinuation) of all antihypertensive medication by at least 50% for at least six months or two cycles Ultratrace Iobenguane I 131. [ Time Frame: 12 Months ]

Current Secondary Outcome:

  • Proportion of subjects with overall tumor response of Complete Response or Partial Response by RECIST criteria [ Time Frame: 24 Months ]
  • Safety assessed by changes in lab values, physical exams or vital signs, and the occurrence of treatment emergent adverse events [ Time Frame: 12 Months ]
  • Changes from baseline in overall quality of life [ Time Frame: 12 Months ]
  • Overall survival [ Time Frame: 5 Years ]


Original Secondary Outcome:

  • Proportion of subjects with overall tumor response of Complete Response or Partial Response by RECIST criteria [ Time Frame: 24 Months ]
  • Safety assessed by changes in lab values, physical exams or vital signs, and the occurrence of treatment emergent adverse events [ Time Frame: 24 Months ]


Information By: Molecular Insight Pharmaceuticals, Inc.

Dates:
Date Received: April 1, 2009
Date Started: June 2009
Date Completion: June 2021
Last Updated: March 6, 2017
Last Verified: March 2017