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

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ClinicalTrials.gov Identifier: NCT03406273
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Giselle Sholler, Spectrum Health Hospitals

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) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

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])




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. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 8 years ]
    Overall survival (OS) will be defined as the period in days from the date of enrollment until the date of death.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406273


Contacts
Contact: Julie Steinbrecher, RN 616-267-0334 Julie.Steinbrecher@helendevoschildrens.org

Locations
United States, Michigan
Helen DeVos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Julie Steinbrecher    616-267-0334    Julie.Steinbrecher@helendevoschildrens.org   
Principal Investigator: Kaveh Asadi-Moghaddam, MD         
Principal Investigator: Giselle Sholler, MD         
Sponsors and Collaborators
Giselle Sholler
Investigators
Study Chair: Kaveh Asadi-Moghaddam, MD Spectrum Health Hospitals
Study Chair: Giselle Sholler, MD Spectrum Health Hospitals

Additional Information:
Responsible Party: Giselle Sholler, Beat Childhood Cancer Chair, Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT03406273     History of Changes
Other Study ID Numbers: HITC001
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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
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