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

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG) can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine tumors. The safety of this treatment will also be studied.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: 3-Iodobenzylguanidine

Criteria

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.