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

Giselle Sholler

Status: Withdrawn

Conditions: Relapsed Neuroblastoma

Treatments: Radiation: Cerebral Spinal (CS) radiation; Radiation: Focal radiotherapy (SRS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03406273

HITC001

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

≥ 5 years of age

Experimental group

Description:

Cerebral Spinal (CS) radiation

Treatment:

Radiation: Cerebral Spinal (CS) radiation

< 5 yo and ≥ 3 yo and CSF +

Experimental group

Description:

Cerebral Spinal (CS) radiation

Treatment:

Radiation: Cerebral Spinal (CS) radiation

All < 3 yo & < 5 yo/≥ 3 yo CSF neg

Experimental group

Description:

Focal radiotherapy (SRS)

Treatment:

Radiation: Focal radiotherapy (SRS)