Relapsed NeuroblastomaNCT03406273
Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma
A study testing Cerebral Spinal (CS) radiation and Focal radiotherapy (SRS) in people with Relapsed Neuroblastoma, run by Giselle Sholler at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Relapsed Neuroblastoma
- What is being tested?
- Cerebral Spinal (CS) radiation and Focal radiotherapy (SRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2017to 11 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
About this study
Official title: A Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma
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.
- Conditions
- Relapsed Neuroblastoma
- Being tested
- Cerebral Spinal (CS) radiation, Focal radiotherapy (SRS)
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Spinal (CS) radiationRadiation
Surgery plus Cerebral Spinal (CS) radiation
Focal radiotherapy (SRS)Radiation
Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed [SRS])
| Study group | Role | What they receive |
|---|---|---|
| ≥ 5 years of age | Experimental | Cerebral Spinal (CS) radiation Receives: Radiation: Cerebral Spinal (CS) radiation |
| < 5 yo and ≥ 3 yo and CSF + | Experimental | Cerebral Spinal (CS) radiation Receives: Radiation: Cerebral Spinal (CS) radiation |
| All < 3 yo & < 5 yo/≥ 3 yo CSF neg | Experimental | Focal radiotherapy (SRS) Receives: Radiation: Focal radiotherapy (SRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (3)
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
Measured: 3 years
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
Measured: 3 years
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.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startMay 2017 (estimated)
- Primary completion1 May 2017
- Study completion11 Dec 2019
Why it stopped: No enrollment to study, study closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed NeuroblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giselle Sholler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giselle Sholler, Milton S. Hershey Medical Center
- Investigators
- Kaveh Asadi-Moghaddam, MD, Study chair, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406273
- Sponsor's protocol ID
- HITC001
- Status last verified
- Sep 2023
- First submitted
- 8 Jan 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Standardized Protocol of Surgery and Radiation for Patients With Brain Metastases in Relapsed Neuroblastoma
- ClinicalTrials.gov ID
- NCT03406273
- Acronym / sponsor ID
- HITC001
- Conditions
- Relapsed Neuroblastoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment to study, study closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Giselle ShollerUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ≥ 5 years of age | Experimental | Radiation: Cerebral Spinal (CS) radiationCerebral Spinal (CS) radiation |
| < 5 yo and ≥ 3 yo and CSF + | Experimental | Radiation: Cerebral Spinal (CS) radiationCerebral Spinal (CS) radiation |
| All < 3 yo & < 5 yo/≥ 3 yo CSF neg | Experimental | Radiation: Focal radiotherapy (SRS)Focal radiotherapy (SRS) |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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:
- Measurable or evaluable disease by Brain MRI.
- Current disease state must be one for which there is currently no known curative therapy.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral Spinal (CS) radiationSurgery plus Cerebral Spinal (CS) radiation | Radiation | < 5 yo and ≥ 3 yo and CSF +, ≥ 5 years of age |
| Focal radiotherapy (SRS)Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed [SRS]) | Radiation | All < 3 yo & < 5 yo/≥ 3 yo CSF neg |
Primary outcome
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.
3 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 3 years
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
Length of time that participants experience Overall Survival (OS)
Time frame: 8 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaveh Asadi-Moghaddam, MD study chair
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral Spinal (CS) radiation and Focal radiotherapy (SRS) in people with Relapsed Neuroblastoma, run by Giselle Sholler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.