Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochrom… (NCT02961491) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
United States
Plain-language summary
The purpose of this sub-study is to provide expanded access of AZEDRA (Ultratrace Iobenguane I 131) and to evaluate the safety and tolerability of AZEDRA in subjects with iobenguane-avid malignant and/or recurrent pheochromocytoma/paraganglioma (PPGL).
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* Able and willing to provide informed consent/assent and comply with protocol requirements
* Documented diagnosis of either pheochromocytoma or paraganglioma that was confirmed by histology or other supportive data (e.g. abnormal MIBG diagnostic study or elevated tumor markers)
* Ineligible for curative surgery for PPGL
* Failed a prior therapy for PPGL or have no alternative indicated therapy available
* Have definitive tumor avidity confirmed by the AZEDRA dosimetry dose
* Life expectancy of at least 6 months per physician
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 mal…