HITC001 is a single institution study to evaluate the efficacy of using a 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Surgery plus Cerebral Spinal (CS) radiation
Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed \[SRS\])
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Overall Response Rate (ORR) of Participants by the presence of radiologically measurable CNS disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans and/or CSF Sampling.
To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria.
Time frame: 3 years
Number of Participants with Adverse Events as a Measure of Safety
To determine the safety of using a standardized protocol of surgery and radiation for patients with brain metastases in relapse neuroblastoma
Time frame: 3 years
Progression Free Survival (PFS) interval for CNS lesions will be measured by days from start of treatment (surgery/radiation) to the date of any future progressive disease (PD) in CNS lesions per RESIST criteria.
Time to progression (PFS), defined as the period from the start of the treatment until the criteria for progression are met taking as reference the screening measurements
Time frame: 3 years
Length of time that participants experience Overall Survival (OS)
Overall survival (OS) will be defined as the period in days from the date of enrollment until the date of death.
Time frame: 8 years
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