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

Phase 3
2 Years
Not Enrolling
Neuroendocrine Tumors, Metastases, Neoplasm

Thank you

Trial Information

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

MIBG is used to visualize a group of specific cells in the body. It has been known to
deliver the radioactive iodine to the tumor (cancer) cells selectively and result in their

Before treatment starts, patients will be evaluated with a tracer scan, using either I-131
MIBG or I-123 MIBG to locate the tumor site(s). If no MIBG accumulation can be found within
tumor sites, the patient will not be able to continue on this study. Patients will also
have CT scans and urine and blood tests. Women able to have children will have a pregnancy

If tumor sites are found and patients are fully eligible, they will receive a therapeutic
(treatment) dose of I-131 MIBG by vein over 120 minutes. Some patients may have to receive
a lower dose of MIBG. Patients will require hospitalization for treatment and will remain
hospitalized for about 3-6 days.

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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Donald Podoloff, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2001

Completion Date:

January 2005

Related Keywords:

  • Neuroendocrine Tumors
  • Metastases, Neoplasm
  • Metastatic neuroendocrine tumors
  • Neoplasms
  • Neoplasm Metastasis
  • Neuroendocrine Tumors



University of Texas MD Anderson Cancer Center Houston, Texas  77030