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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03406273
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 31.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed Neuroblastoma	Radiation: Cerebral Spinal (CS) radiation; Radiation: Focal radiotherapy (SRS)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma
• Anticipated Study Start Date: May 1, 2017
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: Dec 11, 2019

Arms and Interventions

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])

Outcome Measures

Primary Outcome Measures

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. [3 years]

   To determine the activity of treatments chosen based on Overall response rate (ORR) using RESIST criteria.

Secondary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety [3 years]

   To determine the safety of using a standardized protocol of surgery and radiation for patients with brain metastases in relapse neuroblastoma

2. 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]

   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. Length of time that participants experience Overall Survival (OS) [8 years]

   Overall survival (OS) will be defined as the period in days from the date of enrollment until the date of death.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helen DeVos Children's Hospital	Grand Rapids	Michigan	United States	49503

Sponsors and Collaborators

• Wake Forest University Health Sciences

Investigators

• Study Chair: Kaveh Asadi-Moghaddam, MD, Spectrum Health Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03406273
• Other Study ID Numbers: HITC001
• First Posted: Jan 23, 2018
• Last Update Posted: Apr 27, 2022
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuroblastoma; Brain Neoplasms

Study Results

No Results Posted as of Apr 27, 2022