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

Completed · Phase 3

Conditions studied: Neuroendocrine Tumors, Metastases, Neoplasm

In brief

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.

Key facts

Study ID

NCT00037869

Run by

M.D. Anderson Cancer Center

People needed

15

Starts

2001-11-01

Expected to finish

2005-01-01

Last updated by the study team

2018-10-31

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Histologically documented neuroendocrine tumor.
• Labeled MIBG concentration in the tumor site(s) on diagnostic scan.
• 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.

You may not qualify if…

• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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