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

NCT00293319 | Completed Phase 2

• 3 other identifiers: CDR0000454716UCSF-05161UCSF-00161
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 3

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.

Conditions

Neuroblastoma

Keywords

recurrent neuroblastoma

Outcome Measures

Primary Outcomes (2)

• Ability of iodine I 131 metaiodobenzylguanidine to provide palliative therapy

• Acute and late toxicities

Secondary Outcomes (1)

• Disease and symptom responses

Interventions

filgrastim BIOLOGICAL

iobenguane I 131 RADIATION

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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 in refractory neuroblastoma. J Clin Oncol. 2007 Mar 20;25(9):1054-60. doi: 10.1200/JCO.2006.09.3484.

  PMID: 17369569 RESULT

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; 3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated

Study Officials

• Katherine K. Matthay, MD

  University of California, San Francisco

  STUDY CHAIR

• John M. Maris, MD

  Children's Hospital of Philadelphia

• Robert Goldsby, MD

  University of California, San Francisco

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: April 1, 2005
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

US (3)