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

Relapsed Neuroblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03406273
• Other study ID #: HITC001
• Status: Withdrawn
• Phase: N/A
• Start date: May 2017
• Est. completion date: December 11, 2019

Study information

• Verified date: September 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 11, 2019
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Neuroblastoma
• Relapsed Neuroblastoma

Intervention

Radiation:
• Cerebral Spinal (CS) radiation
Surgery plus Cerebral Spinal (CS) radiation
• Focal radiotherapy (SRS)
Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed [SRS])

Locations

Country	Name	City	State
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Giselle Sholler

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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