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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2019-12-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Relapsed Neuroblastoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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≥ 5 years of age

Cerebral Spinal (CS) radiation

Group Type EXPERIMENTAL

Cerebral Spinal (CS) radiation

Intervention Type RADIATION

Surgery plus Cerebral Spinal (CS) radiation

< 5 yo and ≥ 3 yo and CSF +

Cerebral Spinal (CS) radiation

Group Type EXPERIMENTAL

Cerebral Spinal (CS) radiation

Intervention Type RADIATION

Surgery plus Cerebral Spinal (CS) radiation

All < 3 yo & < 5 yo/≥ 3 yo CSF neg

Focal radiotherapy (SRS)

Group Type EXPERIMENTAL

Focal radiotherapy (SRS)

Intervention Type RADIATION

Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed \[SRS\])

Interventions

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Cerebral Spinal (CS) radiation

Surgery plus Cerebral Spinal (CS) radiation

Intervention Type RADIATION

Focal radiotherapy (SRS)

Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed \[SRS\])

Intervention Type RADIATION

Eligibility Criteria

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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.
* 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

* 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.

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No