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

NCT00037869 | Completed Phase 3

• 1 other identifier: ID01-063
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuroendocrine Tumors; Metastases, Neoplasm

Keywords

Metastatic neuroendocrine tumors

Study Arms (1)

MIBG

EXPERIMENTAL

High Dose I-131 Metaiodobenzylguanidine

Drug: I-131 Metaiodobenzylguanidine

Interventions

I-131 Metaiodobenzylguanidine DRUG

Also known as: MIBG

MIBG

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Neoplasm Metastasis

Interventions

3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated

Study Officials

• Donald Podoloff, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2002
• First Posted: May 27, 2002
• Study Start: November 1, 2001
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)