A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
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.
Radiation: Ultratrace® Iobenguane I131
Access to an investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma|
- 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 ] [ Designated as safety issue: No ]
- Proportion of subjects with overall tumor response of Complete Response or Partial Response by RECIST criteria [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Safety assessed by changes in lab values, physical exams or vital signs, and the occurrence of treatment emergent adverse events [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
- Changes from baseline in overall quality of life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||June 2021|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
|Experimental: Ultratrace® Iobenguane I 131 Treatment||
Radiation: Ultratrace® Iobenguane I131
Each subject will be administered 3 mCi to 6 mCi Ultratrace® Iobenguane I 131, referred to as the Imaging Dose, to confirm that subject meets radiological entry criteria and to establish dosimetry. All subjects meeting entry criteria will then receive the investigational product referred to as the Therapeutic Dose (500 mCi or 8 mCi/kg if the subject weighs 62.5 kg or less) of Ultratrace Iobenguane I 131, followed by imaging at 7 days post infusion or upon discharge from isolation. The Therapeutic Doses will be adjusted equally if warranted by results of the dosimetry evaluation. At least 3 months later, subjects will receive the second Therapeutic Dose.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874614
|United States, California|
|University of California-San Francisco|
|San Francisco, California, United States, 94143|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Missouri|
|Washington University School of Medicine, Alvin J. Siteman Cancer Center|
|St. Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Bennett Chin, MD||Duke University|
|Principal Investigator:||Daniel Pryma, MD||University of Pennsylvania|
|Principal Investigator:||Jeffrey Olsen, MD||Mallinckrodt Institute of Radiology Washington University|
|Principal Investigator:||Camillo Jimenez, MD||MD Anderson Cancer|
|Principal Investigator:||Joseph Dillon, MD||University of Iowa|
|Principal Investigator:||Lilja Solnes, MD||Johns Hopkins University|
|Principal Investigator:||Lale Kostakoglu, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Miguel Pampaloni, MD PhD||University of California, San Francisco|