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Trial record 99 of 3173 for:    Neuroendocrine Tumors | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037869
Recruitment Status : Completed
First Posted : May 27, 2002
Last Update Posted : October 31, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Metastases, Neoplasm Drug: I-131 Metaiodobenzylguanidine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose I-131 Metaiodobenzylguanidine (MIBG) Therapy for Metastatic Neuroendocrine Tumors
Study Start Date : November 2001
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Arm Intervention/treatment
Experimental: MIBG
High Dose I-131 Metaiodobenzylguanidine
Drug: I-131 Metaiodobenzylguanidine
Other Name: MIBG

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00037869

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Donald Podoloff, MD M.D. Anderson Cancer Center
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00037869    
Other Study ID Numbers: ID01-063
First Posted: May 27, 2002    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Keywords provided by M.D. Anderson Cancer Center:
Metastatic neuroendocrine tumors
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action