Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)

Inclusion Criteria:

1. Disease not amenable to standard treatment (nonresectable or disease present after oneor more surgeries and/or Sandostatin treatment) or subject has failed existing firstline chemotherapy, biologic therapy, targeted agent therapy or radiation therapy.
2. Participation in Iowa Neuroendocrine Tumor Registry.
3. A pathologically confirmed (histology or cytology) malignant neoplasm with at leastone target lesion that is confirmed by conventional imaging and is determined toexpress somatostatin receptors by 68Ga-DOTATOC (TATE) PET within 6 months prior totreatment with 90Y-DOTATOC.
4. The target lesion is one that either has never received external beam radiation or hasbeen previously irradiated and has since demonstrated progression. Any localirradiation of the target lesion or any non-target lesions via external beam,conformal or stereotactic radiation treatments must have occurred more than 4 weeksprior to study drug administration. Any full cranial-spinal radiation, whether or nota target lesion is included in the field, must have occurred more than 3 months priorto study drug administration.
5. Life expectancy > 2 months at the time of study drug administration.
6. Archival tissue from a previous biopsy will be required.
7. Age ≥ 6 months-90 years at the time of study drug administration.
8. Performance status as determined by Karnofsky ≥ 60 or Lansky Play Scale ≥ 60% at thetime of study drug administration.
9. Completion of Norfolk Quality of Life Questionnaire.
10. Within 7-10 days of study drug administration, patients must have normal organ andmarrow function as defined below:

• absolute neutrophil count >1000/mm3
• Platelets >90,000/mm3
• total bilirubin <3X ULN for age
• AST(SGOT) & ALT(SGPT) <10X institutional upper limit of normal for age
• Urinalysis no greater than 1+ hematuria or proteinuria
• Renal function* Adults(age18 or >): Serum creatinine ≤ 1.2 mg/dl; if serumcreatinine is >1.2 mg/dL, nuclear GFR will be measured. GFR will need to be ≥ 80ml/min/1.73m2 for subjects ≤40 years old, ≥ 70 ml/min/1.73m2 for subjects between 41-50; ≥ 60 ml/min/1.73m2 for subjects between 51-60; ≥ 50 ml/min/1.73m2 forsubjects > 60 years old. Children(age <18): nuclear GFR ≥ 80 mL/min/1.73 m2

• Renal function criteria based on our previous experience with 90Y-DOTATOC therapyand known changes in GFR with age13,21,33-35

11. The effects of 90Y-DOTA-tyr3-Octreotide on the developing human fetus are unknown. Forthis reason and because Class C agents are known to be teratogenic, women and men ofchild-bearing potential must agree to use adequate contraception (hormonal or barriermethod of birth control) prior to study entry and for the duration of studyparticipation. Should a woman become pregnant or suspect she is pregnant whileparticipating in this study, she should inform her treating physician immediately.
12. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Pregnant women are excluded from this study because 90Y-DOTATOC is a Class C agentwith potential teratogenic or abortifacient effects.
2. Because there is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the mother with 90Y-DOTATOC, breastfeeding should bediscontinued until 6 weeks after the last administration of study drug.
3. Surgery within 4 weeks of study drug administration.
4. External beam radiation to both kidneys (scatter doses of <500 cGy to a single kidneyor radiation to < 50% of a single kidney is acceptable).
5. Prior PRRT with 90Y-DOTATOC (TATE) or 177Lu-DOTATOC (TATE) or 131I-MIBG therapy forthis malignancy.
6. Another investigational drug within 4 weeks of study drug administration.
7. Concurrent, malignant disease for which patient is on active therapy.
8. Another significant medical, psychiatric, or surgical condition which is currentlyuncontrolled by treatment and which would likely affect the subject's ability tocomplete this protocol.
9. Any subject for whom, in the opinion of their physician, a 12-hour discontinuation ofsomatostatin analogue therapy represents a health risk. Also subjects who havereceived SandostatinLAR 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 thetime from last injection of long-acting somatostatin analogue until 12 hrs prior toinjection of study drug. Known antibodies to Octreotide, Lanreotide, or DOTATOC orhistory of allergic reactions attributed to compounds of similar chemical or biologiccomposition to 90Y-DOTATOC.
10. Patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas ormitomycin C) of study drug administration or those who have not recovered from adverseevents due to agents administered more than 4 weeks earlier.
11. Uncontrolled illness including, but not limited to ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, orpsychiatric illness/social situations that would limit compliance with studyrequirements.
12. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will notbe able to fit inside the imaging machines.)
13. Inability to lie still for the entire imaging time (due to cough, severe arthritis,etc.)