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

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

Details

• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.
• Treatments: 3-Iodobenzylguanidine

Criteria

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