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

Primary Purpose

Neuroendocrine Tumors, Metastases, Neoplasm

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
I-131 Metaiodobenzylguanidine
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Metastatic neuroendocrine tumors

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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. 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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIBG

Arm Description

High Dose I-131 Metaiodobenzylguanidine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 24, 2002
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00037869
Brief Title
High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine Tumors
Official Title
High Dose I-131 Metaiodobenzylguanidine (MIBG) Therapy for Metastatic Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 destruction. 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 test. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors, Metastases, Neoplasm
Keywords
Metastatic neuroendocrine tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIBG
Arm Type
Experimental
Arm Description
High Dose I-131 Metaiodobenzylguanidine
Intervention Type
Drug
Intervention Name(s)
I-131 Metaiodobenzylguanidine
Other Intervention Name(s)
MIBG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Podoloff, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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