131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma

August 14, 2014 updated by: Katherine Matthay, University of California, San Francisco

I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study

RATIONALE: Radioactive drugs, such as 131 I-MIBG, may carry radiation directly to tumor cells and not harm normal cells.

PURPOSE: This phase II trial is studying how well 131 I-MIBG works in treating patients with refractory or relapsed neuroblastoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine if iodine I 131 metaiodobenzylguanidine can provide palliative therapy for patients with refractory or relapsed neuroblastoma.
  • Determine the acute and late toxicity of this regimen in these patients.

Secondary

  • Determine disease and symptom responses of patients treated with this regimen.

OUTLINE: This is a compassionate use study.

Patients receive iodine I 131 metaiodobenzylguanidine IV over 2 hours. Beginning 10 days later, patients with low neutrophil counts receive filgrastim (G-CSF) subcutaneously until blood count recovers. Patients with stable or responding disease may receive a second dose of iodine I 131 metaiodobenzylguanidine at least 6 weeks after the first dose.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0942
        • University of Michigan Comprehensive Cancer Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Original diagnosis of neuroblastoma based on 1 of the following criteria:

    • Histopathology
    • Elevated urine catecholamines with typical tumor cells in the bone marrow

  • Refractory or relapsed disease, meeting 1 of the following criteria:

    • Failure to respond to standard therapy (e.g., combination chemotherapy with or without radiotherapy and surgery)
    • Evidence of disease progression (i.e., any new lesion or an increase in size of > 25% of a pre-existing lesion) at any time
  • Evaluable disease by MIBG scan within 6 weeks of study entry

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • Bilirubin < 2 times normal
  • AST/ALT ≤ 10 times normal
  • Creatinine ≤ 2 mg/dL
  • Absolute neutrophil count* ≥ 750/mm^3 (transfusion independent)
  • Platelet count* ≥ 50,000/mm^3 (20,000/mm^3 if stem cells are available and platelet transfusion independent)
  • Hemoglobin* ≥ 10 g/dL (transfusion allowed)
  • No dyspnea at rest
  • No exercise intolerance
  • No oxygen requirement
  • No clinically significant cardiac dysfunction
  • No disease of any major organ system that would preclude study compliance
  • No active infection that meets grade 3 or 4 toxicity criteria NOTE: *Patients with granulocytopenia and/or thrombocytopenia due to tumor metastases to the bone marrow may be eligible at the discretion of the principal investigator

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior therapy
  • At least 2 weeks since prior antitumor therapy

  • At least 3 months since prior radiotherapy to any of the following fields:

    • Craniospinal
    • Total abdominal
    • Whole lung
    • Total body
  • At least 1 day since prior cytokine therapy (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], interleukin-6, or epoetin alfa)
  • Prior iodine I 131 metaiodobenzylguanidine allowed provided it was given more than 6 months ago AND patient has adequate hematopoietic stem cells available
  • No concurrent hemodialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
Acute and late toxicities

Secondary Outcome Measures

Outcome Measure
Disease and symptom responses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Katherine K. Matthay, MD, University of California, San Francisco
  • John M. Maris, MD, Children's Hospital of Philadelphia
  • Robert Goldsby, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

February 16, 2006

First Submitted That Met QC Criteria

February 16, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 14, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000454716
  • UCSF-05161
  • UCSF-00161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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