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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Edward Coleman, MD
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|University of Iowa||Iowa City, Iowa 52242|
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Mount Sinai School of Medicine||New York, New York 10029|
|Rhode Island Hospital||Providence, Rhode Island 02903|
|University of California-San Francisco||San Francisco, California 94143|
|Duke University Medical Center||Durham, North Carolina 27710|
|Hospital of the University of Pennsylvania||Philadelphia, Pennsylvania 19104|
|University Of Miami Miller School Of Medicine||Miami, Florida 33010|
|Louisana State University Health Sciences Center||Shreveport, Louisiana 71103|
|Washington University School of Medicine, Alvin J. Siteman Cancer Center||St. Louis, Missouri 63110|