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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Relapsed Neuroblastoma
• Intervention / Treatment: Radiation: Cerebral Spinal (CS) radiation; Radiation: Focal radiotherapy (SRS)

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Helen DeVos Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ≥ 5 years of age; Cerebral Spinal (CS) radiation	Radiation: Cerebral Spinal (CS) radiation; Surgery plus Cerebral Spinal (CS) radiation
Experimental: < 5 yo and ≥ 3 yo and CSF +; Cerebral Spinal (CS) radiation	Radiation: Cerebral Spinal (CS) radiation; Surgery plus Cerebral Spinal (CS) radiation
Experimental: All < 3 yo & < 5 yo/≥ 3 yo CSF neg; Focal radiotherapy (SRS)	Radiation: Focal radiotherapy (SRS); Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed [SRS])

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	8 years

Collaborators and Investigators

• Sponsor: Giselle Sholler
• Investigators: Study Chair: Kaveh Asadi-Moghaddam, MD, Spectrum Health Hospitals

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2017
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): December 11, 2019

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 12, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Brain Neoplasms; Neuroblastoma
• Other Study ID Numbers: HITC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No