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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00037869
First received: May 24, 2002
Last updated: July 31, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Neuroendocrine Tumors
Metastases, Neoplasm
Drug: I-131 Metaiodobenzylguanidine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose I-131 Metaiodobenzylguanidine (MIBG) Therapy for Metastatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 15
Study Start Date: November 2001
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIBG
High Dose I-131 Metaiodobenzylguanidine
Drug: I-131 Metaiodobenzylguanidine
Other Name: MIBG

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037869

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Donald Podoloff, MD M.D. Anderson Cancer Center
  More Information

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00037869     History of Changes
Other Study ID Numbers: ID01-063
Study First Received: May 24, 2002
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Metastatic neuroendocrine tumors

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neuroendocrine Tumors
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplastic Processes
Neuroectodermal Tumors
Pathologic Processes
3-Iodobenzylguanidine
Antineoplastic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014