Expanded Access Program of Ultratrace Iobenguane I131 for Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
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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).
Condition or disease
Drug: Ultratrace Iobenguane I131
MIP-IB12B, the pivotal phase 2 study evaluating efficacy and safety of AZEDRA in patients with malignant relapsed/refractory PPGL, has completed its anticipated enrollment. The purpose of this sub-study, MIP-IB12B-EAP, is to provide expanded access to AZEDRA for newly enrolled subjects with iobenguane-avid metastatic and/or recurrent PPGL and to collect additional safety data.
Subjects will receive a dosimetry dose of AZEDRA and will undergo 3 whole body scans. If the scans indicate tumor avidity for AZEDRA, the subjects will receive up to 2 therapeutic doses of AZEDRA each at 500 mCi (or 8 mCi/kg, for subjects weighing 62.5 kg or less) approximately 90 days apart.
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Ages Eligible for Study:
12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
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
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