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

Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293319
• Other study ID #: CDR0000454716
• Secondary ID: UCSF-05161UCSF-0
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2006
• Last updated: August 14, 2014
• Start date: April 2005
• Est. completion date: March 2006

Study information

• Verified date: August 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Biological:
• filgrastim

Radiation:
• iobenguane I 131

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UCSF Comprehensive Cancer Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy			No
Primary	Acute and late toxicities			Yes
Secondary	Disease and symptom responses			No