Yttrium Y 90-Edotreotide with PET/CT in Treating Patients with Somatostatin Receptor Positive Tumors

Inclusion Criteria

• Disease not amenable to standard treatment (nonresectable or disease present after one or more surgeries and/or Sandostatin treatment) or subject has failed existing first line chemotherapy, biologic therapy, targeted agent therapy or radiation therapy
• Participation in Iowa Neuroendocrine Tumor Registry
• A pathologically confirmed (histology or cytology) malignant neoplasm with at least one target lesion that is confirmed by conventional imaging and is determined to express somatostatin receptors by 68Ga-DOTATOC (TATE) PET within 6 months prior to treatment with 90Y-DOTATOC
• The target lesion is one that either has never received external beam radiation or has been previously irradiated and has since demonstrated progression; any local irradiation of the target lesion or any non-target lesions via external beam, conformal or stereotactic radiation treatments must have occurred more than 4 weeks prior to study drug administration; any full cranial-spinal radiation, whether or not a target lesion is included in the field, must have occurred more than 3 months prior to study drug administration
• Life expectancy >= 2 months at the time of study drug administration
• Archival tissue from a previous biopsy will be required
• Performance status as determined by Karnofsky >= 60 or Lansky play scale >= 60% at the time of study drug administration
• Completion of Norfolk Quality of Life Questionnaire
• Absolute neutrophil count >= 1000/mm^3 (within 7-10 days of study drug administration)
• Platelets >= 90,000/mm^3 (within 7-10 days of study drug administration)
• Total bilirubin < 3 X upper limit of normal (ULN) for age (within 7-10 days of study drug administration)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 10 X institutional upper limit of normal for age (within 7-10 days of study drug administration)
• Urinalysis no greater than 1+ hematuria or proteinuria (within 7-10 days of study drug administration)
• Renal function (within 7-10 days of study drug administration) * Adults (age 18 or >): Serum creatinine =< 1.2 mg/dl; if serum creatinine is > 1.2 mg/dL, nuclear glomerular filtration rate (GFR) will be measured ** GFR will need to be >= 80 ml/min/1.73 m^2 for subjects =< 40 years old ** >= 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 > 60 years old * Children (age < 18): nuclear GFR >= 80 mL/min/1.73 m^2 * Renal function criteria based on previous experience with 90Y-DOTATOC therapy and known changes in GFR with age
• The effects of 90Y-DOTA-tyr3-octreotide on the developing human fetus are unknown; for this reason and because class C agents are known to be teratogenic, 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 the duration of study participation; 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 sign a written informed consent document

Exclusion Criteria

• Pregnant women are excluded from this study because 90Y-DOTATOC is a Class C agent with potential teratogenic or abortifacient effects
• Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 90Y-DOTATOC, breastfeeding should be discontinued until 6 weeks after the last administration of study drug
• Surgery within 4 weeks of study drug administration
• External beam radiation to both kidneys (scatter doses of < 500 cGy to a single kidney or radiation to < 50% of a single kidney is acceptable)
• Prior PRRT with 90Y-DOTATOC (TATE) or 177Lu-DOTATOC (TATE) or 131I-MIBG therapy for this malignancy
• Another investigational drug within 4 weeks of study drug administration
• Concurrent, malignant disease for which patient is on active therapy
• Another significant medical, psychiatric, or surgical condition which is currently uncontrolled by treatment and which would likely affect the subject's ability to complete this protocol
• Any subject for whom, in the opinion of their physician, a 12-hour discontinuation of somatostatin analogue therapy represents a health risk; also subjects who have received Sandostatin long-acting release (LAR) in the past 28 days or long-acting lanreotide within the past 8 weeks are excluded; subjects may be maintained on short acting octreotide during the time from last injection of long-acting somatostatin analogue until 12 hours (hrs) prior to injection of study drug; known antibodies to octreotide, lanreotide, or DOTATOC or history of allergic reactions attributed to compounds of similar chemical or biologic composition to 90Y-DOTATOC
• Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of study drug administration or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Uncontrolled 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
• Subject weighs more than 450 pounds (Subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines)
• Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)