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

NCT00874614 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2020-02-20

Study results available
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Summary

This clinical trial is designed to evaluate the effectiveness and collect additional safety information on AZEDRA® (iobenguane I 131) for the treatment of metastatic or relapsed/refractory (to other treatment) or unresectable pheochromocytoma or paraganglioma.

The purpose of this trial is to test the use of AZEDRA® as a treatment for pheochromocytoma and paraganglioma, a rare disease. 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 therapeutic doses given approximately 3 months apart.

Conditions

  • Pheochromocytoma
  • Paraganglioma

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.

Sponsors & Collaborators

  • Molecular Insight Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Bennett Chin, MD · Duke University

  • Daniel Pryma, MD · University of Pennsylvania

  • Jeffrey Olsen, MD · Mallinckrodt Institute of Radiology Washington University

  • Camillo Jimenez, MD · MD Anderson Cancer

  • Joseph Dillon, MD · University of Iowa

  • Lilja Solnes, MD · Johns Hopkins University

  • Lale Kostakoglu, MD · Icahn School of Medicine at Mount Sinai

  • Michael H Pampaloni, MD · University of California at San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-04
Primary Completion
2017-02-14
Completion
2021-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00874614 on ClinicalTrials.gov