Trial · NCT02559778
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
NCT02559778, Phase 2, Recruiting, Giselle Sholler
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pediatric Precision Laboratory Advanced Neuroblastoma Therapy. Trials, record NCT02559778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02559778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
- NCT number
- NCT02559778
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Giselle Sholler
- Conditions
- Neuroblastoma
- Interventions
- Ceritinib, dasatinib, sorafenib, vorinostat, DFMO
- First posted
- 2015-09-24
- Last updated
- 2026-09-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of days from start of therapy to date of first relapse | Up to 8 years | To measure the response of treatments chosen based on: • Event free survival (EFS) |
| Primary | Number of subjects that have a targeted agent chosen for treatment. | 2 years | At completion of the induction therapy, the investigators will determine feasibility of adding molecularly guided targeted therapy to standard of care chemotherapy. Feasibility will be defined as: 1. Subject has a targeted agent identified 2. Receives 75% of dosing of medications while on study protocol during cycles 3-6 3. Subject is not removed from study due to targeted agent drug related toxicity. |
| Primary | Number of subjects that receive 75% of dosing of medications while on study protocol during cycles 3-6. | 2 years | At completion of the induction therapy, the investigators will determine feasibility of adding molecularly guided targeted therapy to standard of care chemotherapy. Feasibility will be defined as: 1. Subject has a targeted agent identified 2. Receives 75% of dosing of medications while on study protocol during cycles 3-6 3. Subject is not removed from study due to targeted agent drug related toxicity. |
| Secondary | Number of days that subjects remain alive | 3 years plus 5 years follow up | To measure the response of treatments chosen based on: * Overall response rate (ORR) after induction therapy * Overall survival (OS) |
| Secondary | Overall Response Rate (ORR) of Participants by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans. | Up to 8 years | To measure the response of treatments chosen based on: • Overall response rate (ORR) after induction therapy |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 3 years | To compare toxicity effects of difluoromethylornithine (DFMO) in combination with anti-GD2 immunotherapy and isotretinoin versus anti-GD2 immunotherapy and isotretinoin alone. |
| Secondary | Amount of pain medicine required by Arm A versus Arm B | 3 years | To compare level of pain medicine needed during immunotherapy in patients receiving difluoromethylornithine (DFMO) in combination with anti-GD2 immunotherapy and Isotretinoin versus those receiving anti-GD2 immunotherapy and isotretinoin alone. |
| Secondary | Number of subjects required to go off therapy due to treatment-related adverse events as assessed by CTCAE v4.0. | 1 year | At completion of the induction therapy, the investigators will determine feasibility of adding molecularly guided targeted therapy to standard of care chemotherapy. Feasibility will be defined as: 1. Subject has a targeted agent identified 2. Receives 75% of dosing of medications while on study protocol during cycles 3-6 3. Subject is not removed from study due to targeted agent drug related toxicity. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02559778
GET https://conductscience.org/api/trials/v1/NCT02559778/registered