Iodine I 131 Metaiodobenzylguanidine, Combination Chemotherapy, and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell or Bone Marrow Transplant for Relapsed or Refractory Neuroblastoma

OBJECTIVES:

Primary

- Determine the response rate in patients with relapsed or refractory neuroblastoma
treated with iodine I 131 metaiodobenzylguanidine (^131I-MIBG) and combination
chemotherapy comprising carboplatin, etoposide, and melphalan followed by autologous
bone marrow or peripheral blood stem cell transplantation and radiotherapy.

Secondary

- Determine the hematopoietic and nonhematopoietic toxicity of this regimen in these
patients.

- Determine the tumor self-absorbed radiation dose (TSARD) in patients with measurable
soft tissue lesions treated with this regimen.

- Correlate the TSARD with tumor response in patients with measurable residual soft
tissue disease treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (poor-risk
group [mixed or no response to induction therapy or progression during or after induction
therapy] vs good-risk group [partial response after 4 courses of induction therapy]) and
kidney function at study entry (glomerular filtration rate [GFR] ≥ 100 mL/min vs GFR 60-99
mL/min)

- Stem cell harvest: Patients undergo a peripheral blood stem cell harvest or bone marrow
harvest provided they have an adequate number of cells available. At least 2 weeks
later, patients proceed to iodine I 131 metaiodobenzylguanidine (^131I-MIBG) and
combination chemotherapy.

- 131I-MIBG and combination chemotherapy: Patients receive ^131I-MIBG IV over 2 hours on
day -21, carboplatin IV continuously on days -7 to -4, etoposide IV continuously on
days -7 to -4, and melphalan IV over 1 hour on days -7 to -5.

- Stem cell infusion and filgrastim (G-CSF): Three days after completion of chemotherapy,
patients undergo transplantation of either stem cells or bone marrow on day 0. Patients
also receive G-CSF subcutaneously or IV over 1 hour once daily beginning on day 0 and
continuing until blood counts return to normal.

- Radiotherapy: Once blood counts return to normal, patients undergo radiotherapy to
primary and metastatic sites that have not received previous irradiation over 12 days
beginning after day 42.

After completion of study treatment, patients are followed for 2 years and then periodically
thereafter.

PROJECTED ACCRUAL: Approximately 50 patients (40 low-risk patients and 8-10 high-risk
patients) will be accrued for this study.