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ANBL09P1: A COG Pilot Study of Intensive Induction Therapy and 131I-MIBG With Myeloablative Carboplatin, Etoposide and Melphalan (CEM) for Newly Diagnosed High-Risk Neuroblastoma

What is the purpose of this study?

Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy.

This clinical trial is studying induction therapy followed by iobenguane I 131 and high-dose chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin.

Who can participate?

1 to 30 years of age

Disease Characteristics:

Diagnosis of neuroblastoma (ICD-O morphology 9500/3) or ganglioneuroblastoma by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites meeting 1 of the following staging criteria:
- Newly diagnosed International Neuroblastoma Staging System (INSS) stage 4 disease meeting 1 of the following criteria:

MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals) and age ≥ 365 days regardless of additional biologic features
Age > 18 months (> 547 days) regardless of biologic features
Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features: MYCN amplification, unfavorable pathology, and/or DNA index = 1, or any biologic feature that is indeterminant, unsatisfactory, or unknown

Newly diagnosed INSS stage 3 disease meeting 1 of the following criteria:

MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals) and age ≥ 365 days, regardless of additional biologic features
Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status

Newly diagnosed INSS stage 2a/2b with MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals) and age ≥ 365 days, regardless of additional biologic features
Age ≥ 365 days initially diagnosed with INSS stage 1, 2, or 4S who progressed (within the past 4 weeks) to a stage 4 without interval chemotherapy
No patients aged 12-18 months with INSS stage 4 and all 3 favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and DNA index > 1)

Must be enrolled onto ANBL00B1 biologic study
Must have ≥ 1 "MIBG-avid target lesion" present on MIBG scan in the past 4 weeks

Patient Characteristics:

Total bilirubin ≤1.5 times upper limit of normal (ULN)
AST or ALT ≤ 10 times ULN

Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age and/or gender as follows:

≤ 0.6 mg/dL (1 to < 2 years of age)
≤ 0.8 mg/dL (2 to < 6 years of age)
≤ 1.0 mg/dL (6 to < 10 years of age)
≤ 1.2 mg/dL (10 to < 13 years of age)
≤ 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
≤ 1.7 mg/dL (male) or 1.4 mg/dL (female) ( ≥ 16 years of age)

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by radionuclide evaluation

Able to tolerate peripheral blood stem cell (PBSC) collection
No contraindications to PBSC collection including weight, size, or physical condition that would preclude apheresis