CClinicalTrials.gg
Sign In
WithdrawnNCT03406273Updated Sep 28, 2023

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

An interventional study of Cerebral Spinal (CS) radiation and Focal radiotherapy (SRS) in Relapsed Neuroblastoma, sponsored by Giselle Sholler. Withdrawn at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2023-09-28.

Sponsored by Giselle Sholler · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No enrollment to study, study closed
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
Up to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Relapsed Neuroblastoma
03

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    ≥ 5 years of age

    Cerebral Spinal (CS) radiation

    Radiation: Cerebral Spinal (CS) radiation

  • Experimental
    < 5 yo and ≥ 3 yo and CSF +

    Cerebral Spinal (CS) radiation

    Radiation: Cerebral Spinal (CS) radiation

  • Experimental
    All < 3 yo & < 5 yo/≥ 3 yo CSF neg

    Focal radiotherapy (SRS)

    Radiation: Focal radiotherapy (SRS)

Interventions

  • RadiationCerebral Spinal (CS) radiation

    Surgery plus Cerebral Spinal (CS) radiation

  • RadiationFocal radiotherapy (SRS)

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

05

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. 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

    Time frame: 3 years

  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.

    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

  3. 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.

    Time frame: 8 years

06

Study locations

1 site
  • Helen DeVos Children's Hospital
    Grand Rapids, Michigan 49503, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03406273
Lead sponsor
Giselle Sholler
Responsible party
Giselle Sholler (Beat Childhood Cancer Chair, Milton S. Hershey Medical Center) — Sponsor-investigator
First posted
Jan 23, 2018
Start date
May 2017 (estimated)
Primary completion
May 1, 2017
Completion
Dec 11, 2019
Last update
Sep 28, 2023

Study contacts

Kaveh Asadi-Moghaddam, MD
study chair · Spectrum Health Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Brain Neoplasms→

Other studies from this sponsor

Giselle Sholler

Start the discussion