High Dose I-131 Metaiodobenzylguanidine (MIBG) Therapy for Metastatic Neuroendocrine Tumors

Inclusion Criteria:

- Age: 2 years of age and older

- Sex: male or female; female patients with child bearing potential must have a
negative serum HCG pregnancy test within 72 hours prior to treatment;

- Diagnostic criteria- Patients must meet all of the following:

1. Histologically documented neuroendocrine tumor.

2. Labeled MIBG concentration in the tumor site(s) on diagnostic scan.

3. good to excellent performance status.

- A patient for whom written voluntary informed consent has been obtained prior to
study and participation.

- Patients can have had prior chemotherapy, as long as hematological parameters meet
specifications.

- Please refer to Appendix D Drugs and Other Interactions for list of medications
patient needs to cease 2 weeks prior to therapy. Patient should check with primary
physician after therapy about resuming these medications.

- Patients with treatment refractory or relapsed advanced or disease not amendable to
significant response (>25% to available chemotherapy) or metastatic disease not
amenable to standard therapy.

Exclusion Criteria:

- Patients with inadequate hematopoietic bone marrow function: ANC<1000 cells/mm3, or
platelets<75k cells/mm3 or hemoglobin<10g/dL.

- Patients with impaired renal function: creatinine>1.5mg/dL.

- Patients with impaired hepatic function: AST or ALT > 3.0 X upper limit of normal or
total bilirubin > 2.0 mg/dL.

- Patients with dementia or altered mental status that would prohibit the giving and
understanding of informed consent at time of study entry.

- Female patients who are breast-feeding.

- Children less than 2 years of age.

- Patients with previous total body irradiation.