Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma

This clinical trial aims to establish a standardized protocol consisting of surgery and
radiation for patients with brain metastases in relapsed neuroblastoma. This will be an
adjunct study to NMTRC009 onto which patients will be enrolled to for treatment with
precision therapy. This study will follow the efficacy, safety, and CNS progression-free
survival of surgery and radiation.

Inclusion Criteria:

- Age: ≤ 21 years at the time of study entry.

- Diagnosis: Histologic verification at either the time of original diagnosis or relapse
of neuroblastoma.

- Disease Status: Patients must have ONE of the following along with disease in the CNS:

1. Any episode of recurrent disease following completion of aggressive multi-drug
frontline therapy.

2. Any episode of progressive disease during aggressive multi-drug frontline
therapy.

3. Primary resistant/refractory disease detected at the conclusion of at least 4
cycles of aggressive multidrug induction chemotherapy on or according to a
high-risk neuroblastoma protocols.

- Measurable or evaluable disease by Brain MRI.

- Current disease state must be one for which there is currently no known curative
therapy.

- Meet all inclusion criteria for study NMTRC009

- Informed Consent: All subjects and/or legal guardians must sign informed written
consent. Assent, when appropriate, will be obtained according to institutional
guidelines

Exclusion Criteria:

- Meets all exclusion criteria for study NMTRC009

- Subjects who, in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study, or in whom compliance is likely to be
suboptimal, should be excluded.