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

Primary Purpose

Relapsed Neuroblastoma

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cerebral Spinal (CS) radiation

Focal radiotherapy (SRS)

About this trial

This is an interventional treatment trial for Relapsed Neuroblastoma

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Helen DeVos Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

≥ 5 years of age

< 5 yo and ≥ 3 yo and CSF +

All < 3 yo & < 5 yo/≥ 3 yo CSF neg

Arm Description

Cerebral Spinal (CS) radiation

Focal radiotherapy (SRS)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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.

Full Information

NCT ID

NCT03406273

First Posted

January 8, 2018

Last Updated

September 26, 2023

Sponsor

Giselle Sholler

1. Study Identification

Unique Protocol Identification Number

NCT03406273

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Withdrawn

Why Stopped

No enrollment to study, study closed

Study Start Date

May 2017 (Anticipated)

Primary Completion Date

May 1, 2017 (Actual)

Study Completion Date

December 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Giselle Sholler

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed Neuroblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

≥ 5 years of age

Arm Type

Experimental

Arm Description

Cerebral Spinal (CS) radiation

Arm Title

< 5 yo and ≥ 3 yo and CSF +

Arm Type

Experimental

Arm Description

Cerebral Spinal (CS) radiation

Arm Title

All < 3 yo & < 5 yo/≥ 3 yo CSF neg

Arm Type

Experimental

Arm Description

Focal radiotherapy (SRS)

Intervention Type

Radiation

Intervention Name(s)

Cerebral Spinal (CS) radiation

Intervention Description

Surgery plus Cerebral Spinal (CS) radiation

Intervention Type

Radiation

Intervention Name(s)

Focal radiotherapy (SRS)

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events as a Measure of Safety

Description

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

Time Frame

3 years

Title

Description

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

Time Frame

3 years

Title

Length of time that participants experience Overall Survival (OS)

Description

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

Time Frame

8 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaveh Asadi-Moghaddam, MD

Organizational Affiliation

Spectrum Health Hospitals

Official's Role

Study Chair

Facility Information:

Facility Name

Helen DeVos Children's Hospital

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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