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

Primary Purpose

Neuroblastoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
iobenguane I 131
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuroblastoma focused on measuring recurrent neuroblastoma

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Comprehensive Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • Children's Hospital of Philadelphia

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Disease and symptom responses

Full Information

First Posted
February 16, 2006
Last Updated
August 14, 2014
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00293319
Brief Title
131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma
Official Title
I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma, A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma
Keywords
recurrent neuroblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Radiation
Intervention Name(s)
iobenguane I 131
Primary Outcome Measure Information:
Title
Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy
Title
Acute and late toxicities
Secondary Outcome Measure Information:
Title
Disease and symptom responses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine K. Matthay, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John M. Maris, MD
Organizational Affiliation
Children's Hospital of Philadelphia
First Name & Middle Initial & Last Name & Degree
Robert Goldsby, MD
Organizational Affiliation
University of California, San Francisco
Facility Information:
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17369569
Citation
Matthay KK, Yanik G, Messina J, Quach A, Huberty J, Cheng SC, Veatch J, Goldsby R, Brophy P, Kersun LS, Hawkins RA, Maris JM. Phase II study on the effect of disease sites, age, and prior therapy on response to iodine-131-metaiodobenzylguanidine therapy in refractory neuroblastoma. J Clin Oncol. 2007 Mar 20;25(9):1054-60. doi: 10.1200/JCO.2006.09.3484.
Results Reference
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131 I-MIBG in Treating Patients With Refractory or Relapsed Neuroblastoma

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