Iobenguane I-131 and Yttrium Y 90-Edotreotide in Treating Patients with Midgut Neuroendocrine Tumors, Pheochromocytoma, or Paraganglioma

Inclusion Criteria

• STEP I (IMAGING AND DOSIMETRY)
• Pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be: * Well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2), with the primary tumor location should be known or believed to be midgut, or, * Pheochromocytoma, or, * Paraganglioma
• Disease not amenable to curative intent treatment (primarily surgery) and in addition has shown either clinical or radiographic progression on all available (non-radionuclidic) therapies known to confer clinical benefit
• Somatostatin receptor (SSTR) positive sites as demonstrated by either SSTR2 positivity (2+ or 3+ intensity and greater than 10% tumor cell occupying the receptors) or a nuclear medicine scan utilizing 111In-DTPA-phe3-octreotide (Octreosca) or 68Ga-DOTA-tyr3-octreotide within 12 months prior to anticipated cycle 1 day 1 (C1D1) demonstrating SSTR positive tumor sites
• >= 1 tumor site must have demonstrated uptake equal to or greater than normal liver as documented by nuclear scan imaging
• >= 1 evaluable site of disease measuring >= 1.5 cm in diameter on computed tomography (CT) or magnetic resonance imaging (MRI) as measured per Response Evaluation Criteria in Solid Tumors (RECIST)
• Karnofsky performance status >= 70%
• Agrees to contraception; women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for one year following treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to provide informed consent
• STEP II (THERAPY)
• Subjects must demonstrate at least one of the following: * One or more MIBG+ and 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 131I-MIBG and 90Y-DOTATOC than it is with 90Y DOTATOC alone
• Absolute neutrophil count >= 2000 cells/mm^3
• Platelets >= 100,000 cells/mm^3
• Total bilirubin < 1.5 x institutional upper limit of normal (ULN) for age and weight
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x institutional ULN
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN
• Estimated glomerular filtration rate (eGFR) >= 50 mL/min/1.73 m^2 (Cockcroft Gault)

Exclusion Criteria

• STEP I
• Fall risk
• Women who are pregnant or breast feeding; a pregnancy test will be administered to women of child bearing potential (per institutional policies) at screening; women must agree to pregnancy tests prior to (up to 1 calendar day) each administration of a radionuclidic agent, including tracer doses, to be considered for this study
• Surgery, radiation or chemotherapy within 4 weeks of proposed step 1 start date
• Prior peptide-receptor radiotherapy (PRRT)
• Investigational drug within 4 weeks of proposed step 1 start date
• More than one concurrent, malignant disease
• History of congestive heart failure and cardiac ejection fraction =< 40%
• Subjects for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk
• Patients who are unable to discontinue medications known to affect MIBG uptake (unless approved by the principal investigator [P.I.] or designee)
• Proteinuria, grade 2 (i.e., >= 2+ proteinuria)
• Long-acting somatostatin analogue treatment within 14 days of proposed step 1 start date
• Prior external beam radiation involving kidneys (scatter doses of < 500 cGy to a single kidney or radiation to < 50% of a single kidney is acceptable)
• Prior external beam radiation (including brachytherapy) involving 25% of bone marrow (excluding scatter doses of =< 5 Gy)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-DOTA-tyr3-octreotide, Octreoscan, 68Ga-octreotide, or 131I-MIBG
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements