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

Who is this study for? Patients with malignant relapsed/refractory pheochromocytoma/paraganglioma
What treatments are being studied? Ultratrace® Iobenguane I131
Status: Unknown status
Location: See all (10) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: No
View:

• Be at least 12 years of age

• Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma

• Be ineligible for curative surgery for pheochromocytoma

• Have failed a prior therapy for pheochromocytoma/paraganglioma or are not candidates for chemotherapy or other curative therapies

• Be on stable antihypertensive medication for pheochromocytoma-related hypertension for at least 30 days

• Have at least one tumor site by CT or MR or iobenguane I 131 scan

• Have an expected survival of at least 6 months

• Subjects must agree to use an acceptable form of birth control (abstinence, IUD, oral contraception, barrier and spermicide or hormonal implant) during this study and for 6 months following Therapeutic Doses of Ultratrace Iobenguane I 131.

• Male subjects must agree not to father a child during the period beginning immediately after administration of the first Therapeutic Dose of Ultratrace Iobenguane I 131 during the study and ending six months after administration of the last Therapeutic Dose of Ultratrace Iobenguane I 131.

Locations
United States
California
University of California-San Francisco
San Francisco
Florida
University of Miami Miller School of Medicine
Miami
Iowa
University of Iowa
Iowa City
Maryland
Johns Hopkins University
Baltimore
Missouri
Washington University School of Medicine, Alvin J. Siteman Cancer Center
Saint Louis
North Carolina
Duke University Medical Center
Durham
New York
Mount Sinai School of Medicine
New York
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Rhode Island
Rhode Island Hospital
Providence
Texas
MD Anderson Cancer Center
Houston
Time Frame
Start Date: June 4, 2009
Completion Date: February 2021
Participants
Target number of participants: 74
Treatments
Experimental: Ultratrace® Iobenguane I 131 Treatment
Authors
Jeffrey Olsen, Bennett Chin, Lilja Solnes, Daniel Pryma, Joseph Dillon, Camillo Jimenez, Michael H Pampaloni, Lale Kostakoglu, Miguel Pampaloni
Related Therapeutic Areas
Sponsors
Leads: Molecular Insight Pharmaceuticals, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials