Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

Exclusion Criteria

• •Pregnant or nursing females
• •Men or women of childbearing potential and unwilling to use a medically acceptable form of contraception from time of consent until 6 months following last therapeutic dose of AZEDRA
• •Active CNS lesions by CT/MRI within 3 months of informed consent
• •NYHA class IV heart failure, unstable angina pectoris or clinically significant cardiac arrhythmia that poses a risk of syncope or cardiac arrest
• •Prior systemic radiotherapy resulting in marrow toxicity within 3 months of first AZEDRA therapeutic dose
• •Prior iobenguane I 131 therapeutic exposure within 12 weeks of the first planned therapeutic dose
• •Prior administration of whole-body radiation therapy within 12 weeks of the first planned therapeutic dose
• •Prior external beam radiotherapy to \> 25% of bone marrow
• •Prior chemotherapy or investigational compound and/or device within 30 days of the dosimetry dose
• •Other active malignancy requiring additional treatment except for superficial cutaneous neoplasms
• •Karnofsky Performance Status \< 60
• •Clinically significant laboratory abnormalities prior to dosing as listed in the protocol (such as blood count abnormalities, liver enzyme abnormalities, and renal dysfunction)
• •Medical history of AIDS/HIV+
• •Active chronic alcohol abuse, chronic liver disease (not including liver metastases), hepatitis A, B, or C
• •Known allergy to iobenguane that has required medical intervention
• •Receiving a medication which inhibits tumor uptake of iobenguane I 131
• •Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject