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

PHASE2UnknownINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

June 4, 2009

Primary Completion Date

February 14, 2017

Study Completion Date

February 28, 2021

Conditions
PheochromocytomaParaganglioma
Interventions
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.

Trial Locations (10)

10029

Mount Sinai School of Medicine, New York

19104

Hospital of the University of Pennsylvania, Philadelphia

21287

Johns Hopkins University, Baltimore

27710

Duke University Medical Center, Durham

33136

University of Miami Miller School of Medicine, Miami

52242

University of Iowa, Iowa City

63110

Washington University School of Medicine, Alvin J. Siteman Cancer Center, St Louis

77030

MD Anderson Cancer Center, Houston

94143

University of California-San Francisco, San Francisco

02903

Rhode Island Hospital, Providence

All Listed Sponsors
lead

Molecular Insight Pharmaceuticals, Inc.

INDUSTRY