Azedra and Lutathera for the Treatment of Neuroendocrine Tumors

Inclusion Criteria

• STEP 1 INCLUSION CRITERIA:
• Ability to understand and willingness to provide informed consent; legally authorized representative will not be utilized compliant with the principles of good clinical practice (i.e., ICH E6[R2])
• Stated willingness to comply with all study procedures and availability for duration of study
• Aged >= 18 years to 80 years at the time of study drug administration
• Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be a well differentiated or intermediate grade neuroendocrine tumor (i.e. grade 1 or grade 2) with a primary tumor location believed to be foregut, midgut, or hindgut
• Recommended to receive Lutathera or Azedra therapy
• Disease measuring >= 1.5 cm in diameter on computed tomography (CT) or magnetic resonance imaging (MRI) as measured per RECIST
• Adequate performance status (Eastern Cooperative Oncology Group [ECOG] of 0 or 1; or Karnofsky performance status [KPS] of > 70)
• Agrees to contraception during therapy
• Agreement to adhere to lifestyle considerations throughout study duration
• STEP 2 INCLUSION CRITERIA:
• One or more MIBG+ and edotreotide (DOTATOC)‐ tumors in addition to one or more DOTATOC+ tumors
• One or more tumor sites where the calculated "safe" radiation tumor dose is higher by at least 25% with a combination of Azedra and Lutathera than it is with Lutathera alone

Exclusion Criteria

• STEP 1 EXCLUSION CRITERIA
• Eligible for curative surgical resection
• Patient with increased fall risk in the opinion of healthcare professionals
• Women who are pregnant
• Women who are breast feeding
• Surgery, radiation therapy, or chemotherapy =< 4 weeks of cycle (C)1 day (D)1. (Toxicities from prior therapies should have resolved to =< Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or a new baseline established)
• Prior peptide‐receptor radiotherapy (PRRT)
• Therapeutic investigational drug within 4 weeks of C1D1 (imaging agents are acceptable)
• A concurrent malignancy that, in the opinion of the investigator, would cause a safety risk by delaying therapy or confound/negatively impact study objectives (documentation of the rationale must be provided)
• History of congestive heart failure with a history of cardiac ejection fraction =< 35%
• Patients unable to discontinue medications known to affect iobenguane (MIBG) uptake (unless approved by the principal investigator [PI] or designee)
• Proteinuria grade 2 (i.e., >= 2+ proteinuria)
• Prior external beam to the kidneys unless approved by the principal investigator
• Prior external beam radiation (including brachytherapy) involving 25% of the bone marrow (excluding scatter doses of >= 5 Gy) as estimated by a radiation oncologist
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Octreoscan or Netspot