Paraganglioma, Pheochromocytoma
Conditions
Keywords
MIBG, Azedra, Rare neuroendocrine tumors, Iobenguane I 131, Progenics
Brief 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).
Detailed description
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.
Interventions
DRUGUltratrace Iobenguane I131
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.
Sponsors
Molecular Insight Pharmaceuticals, Inc.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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 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
Countries
United States
Outcome results
None listed