Intra-arterial 90Y-DOTATOC in Treating Patients with Liver Neuroendocrine Tumor

Inclusion Criteria

• A pathologically confirmed (histology or cytology) malignant neoplasm that is determined to be well-differentiated neuroendocrine tumor (i.e. grade 1 or grade 2). Biopsy proven neuroendocrine tumor, which is somatostatin receptor positive as demonstrated on somatostatin receptor PET scan. All sites or origin are eligible (foregut, midgut, hindgut)
• Within 6 months from the day of therapy, presence of at least one target lesion in the liver that is confirmed by cross-sectional imaging and is determined to express somatostatin receptors by 68Ga-DOTATATE or 68Ga-DOTATOC with uptake higher than normal liver as measured with 68Ga-DOTATATE or 68Ga-DOTATOC PET/computed tomography (CT)
• Liver lesions not amenable to surgery or ablation therapy and have progressed after first line treatment with octreotide/lanreotide and/or other biological targeted treatments (everolimus and sunitinib) as determined by the patients treating physician
• Age >= 18 years
• Performance status as determined by Karnofsky >= 70% or Eastern Cooperative Oncology Group (ECOG) 1 or 2
• Absolute neutrophil count >= 1000
• Platelet count >= 90,000
• Total bilirubin =< 2 x upper limit of normal (ULN) for age
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5 x institutional upper limit of normal for age
• Serum creatinine =< 1.2 mg/dl; or glomerular filtration rate (GFR) as per below (nuclear GFR measure) * >= 80 ml/min/1.73 m^2 for subjects 40 years and younger * >= 70 ml/min/1.73 m^2 for subjects between 41-50 * >= 60 ml/min/1.73 m^2 for subjects between 51-60 * >= 50 ml/min/1.73 m^2 for subjects older than 60 years old
• Agrees to contraception. The effects of therapeutic levels of 90Y-DOTA-tyr3-3.1.10.Octreotide on the developing human fetus are potentially harmful. For these reasons 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 3 months 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

Exclusion Criteria

• Liver tumor involvement greater than 70% by cross sectional imaging and/or
• Extensive extra-hepatic metastases. Patients with extra-hepatic disease may be enrolled if the disease is predominantly limited to liver. Patient case will be reviewed at the institutions PRRT tumor board to determine if the extent of the extra-hepatic metastases justifies treatment for patients with liver-dominant disease
• Concomitant therapy for neuroendocrine tumor (NET) except for somatostatin analogs or bisphosphonates (somatostatin therapy must be limited to short-acting subcutaneous doses so that it may be suspended 12h before 90Y-DOTATOC)
• Any liver directed treatment (surgery, radioembolization, chemoembolization, chemotherapy, and radiofrequency ablation) within 12 weeks prior to enrollment. Note: Prior systemic PRRT treatment allowed if it was performed at least six months prior to enrollment
• Women who are pregnant, breast feeding or breast pumping. 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
• Another concurrent malignancy on active therapy
• Previous external-beam radiation therapy to both kidneys (scatter doses of < 0.5 Gy to a single kidney or radiation to < 50% of a single kidney is acceptable)
• Therapeutic investigational drug within 4 weeks of therapy
• Subjects for whom, in the opinion of their physician, a 24-hour discontinuation of somatostatin analogue therapy represents a health risk
• Sandostatin long-acting release (LAR) injection within 4 weeks or lanreotide injection within 8 weeks of proposed therapy
• Inability to lie down supine for study procedure
• Reaction to intravenous (IV) contrast used for the angiogram, even if using with premedication. No exclusion if history of contrast reaction but IV contrast used with premedication in the past without any problems
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring hospitalization, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements