Clinical trial · Interventional
Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma
A Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma
NCT03406273CI-TRIAL-00070004withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No enrollment to study, study closed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed Neuroblastoma | Neuroblastoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cerebral Spinal (CS) radiation | Radiation | — | UNRESOLVED |
| Focal radiotherapy (SRS) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ≥ 5 years of age
- description
- Cerebral Spinal (CS) radiation
- interventionNames
- Radiation: Cerebral Spinal (CS) radiation
- type
- EXPERIMENTAL
- label
- < 5 yo and ≥ 3 yo and CSF +
- description
- Cerebral Spinal (CS) radiation
- interventionNames
- Radiation: Cerebral Spinal (CS) radiation
- type
- EXPERIMENTAL
- label
- All < 3 yo & < 5 yo/≥ 3 yo CSF neg
- description
- Focal radiotherapy (SRS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.