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

NCT03406273 | Withdrawn

• 1 other identifier: HITC001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed Neuroblastoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants with Adverse Events as a Measure of Safety

  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.

  3 years

• Length of time that participants experience Overall Survival (OS)

  8 years

Study Arms (3)

≥ 5 years of age

EXPERIMENTAL

Cerebral Spinal (CS) radiation

Radiation: Cerebral Spinal (CS) radiation

< 5 yo and ≥ 3 yo and CSF +

EXPERIMENTAL

Cerebral Spinal (CS) radiation

Radiation: Cerebral Spinal (CS) radiation

All < 3 yo & < 5 yo/≥ 3 yo CSF neg

EXPERIMENTAL

Focal radiotherapy (SRS)

Radiation: Focal radiotherapy (SRS)

Interventions

Cerebral Spinal (CS) radiation RADIATION

Surgery plus Cerebral Spinal (CS) radiation

< 5 yo and ≥ 3 yo and CSF +; ≥ 5 years of age

Focal radiotherapy (SRS) RADIATION

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

All < 3 yo & < 5 yo/≥ 3 yo CSF neg

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• Any episode of recurrent disease following completion of aggressive multi-drug frontline therapy.
• Any episode of progressive disease during aggressive multi-drug frontline therapy.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giselle Sholler: lead

Study Sites (1)

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Neuroblastoma

Interventions

Radiation; Spermine Synthase

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Physical Phenomena; Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Kaveh Asadi-Moghaddam, MD

  Corewell Health West

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Beat Childhood Cancer Chair

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 23, 2018
• Study Start: May 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: December 11, 2019
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)