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

Status unconfirmed · Phase 2

Conditions studied: Pheochromocytoma, Paraganglioma

In brief

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.

Key facts

Study ID

NCT00874614

Run by

Molecular Insight Pharmaceuticals, Inc.

People needed

74

Starts

2009-06-04

Expected to finish

2021-02-01

Last updated by the study team

2020-02-20

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects will be excluded if any of the following conditions are observed:
• <50% of FDG (if data are available) positive lesions are MIBG avid
• Pregnant or nursing females
• Active CNS lesions by CT/MR scanning within 3 months of study entry
• New York Heart Association class IV heart failure, symptomatic congestive heart failure [New York Heart Association class IV with another medical disorder], unstable angina pectoris, cardiac arrhythmia
• Received any previous systemic radiotherapy resulting in marrow toxicity within 3 months of study entry or have active malignancy (other than pheochromocytoma/paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace® iobenguane I 131 trial.
• Administered prior whole-body radiation therapy
• Received external beam radiotherapy to > 25% of bone marrow
• Administered prior chemotherapy within 30 days or have active malignancy (other than pheochromocytoma/ paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace iobenguane I 131 trial.
• Karnofsky Performance Status is < 60
• Platelets < 80,000/μL
• Absolute neutrophil count (ANC) < 1,200/μL, Total bilirubin > 1.5 times the upper limit of normal, AST/SGOT or ALT/SGPT > 2.5 times the upper limit of normal
• Diagnosed with AIDS or HIV-positive
• Active chronic alcohol abuse, chronic liver disease or hepatitis
• Renal dysfunction/impairment
• Known allergy to iobenguane that has required medical intervention
• Received a therapeutic investigational compound and/or medical device/prior chemotherapy within 30 days before admission into this study
• Receiving a medication which inhibits tumor uptake of iobenguane I 131
• Any medical condition or other circumstances (i.e., uncontrolled current illness including but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with the study requirements.
• Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study

Where it is running

• University of California-San Francisco — San Francisco, California, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Washington University School of Medicine, Alvin J. Siteman Cancer Center — St Louis, Missouri, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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