Clinical trial NCT03406273: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Relapsed Neuroblastoma
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 0
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: Length of time that participants experience Overall Survival (OS)
timeFrame: 8 years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
Study officials:
affiliation: Spectrum Health Hospitals
name: Kaveh Asadi-Moghaddam, MD
role: STUDY_CHAIR
References: