Trial · NCT01467986
Multimodal Molecular Targeted Therapy to Treat Relapsed or Refractory High-risk Neuroblastoma
NCT01467986, Phase 2, Completed, University of Regensburg
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multimodal Molecular Targeted Therapy to Treat Relapsed or Refractory High-risk Neuroblastoma. Trials, record NCT01467986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01467986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multimodal Molecular Targeted Therapy to Treat Relapsed or Refractory High-risk Neuroblastoma
- NCT number
- NCT01467986
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- University of Regensburg
- Conditions
- Neuroblastoma Recurrent
- Interventions
- Dasatinib, Rapamycin, Irinotecan, Temozolomide, Irinotecan, Temozolomide
- First posted
- 2011-11-09
- Last updated
- 2020-10-06
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoint is progression-free survival (PFS) | Time interval from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks | The primary objective of this trial is the evaluation of progression-free survival of rNB in children, adolescents and young adults, comparing a multimodal treatment regimen consisting of temozolomide (T), irinotecan (I), rapamycin (R) and dasatinib (S) against irinotecan (I) and temozolomide (T) (I/T) alone |
| Secondary | Overall survival (OS) | Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up | |
| Secondary | Response to the investigational treatment after 4 and 8 courses of I/T and 1-year-follow-up in the RIST treatment arm | Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up | |
| Secondary | Duration until adequate response to this treatment regimen | Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up | |
| Secondary | Assessment of quality of life (Lansky and Karnofsky Scores) | • Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up | |
| Secondary | Toxicity of this combination of drugs in children, adolescents and young adults with rNB | From the first course of the investigational treatment up to the end of the trial assessed to 52 weeks. | Assessment according to the latest version of the CTC criteria. In particular due to the expected AE Profile: * Myelosuppressive measures (RBC, PLT units) * Infectious complications * Gastrointestinal problems |
| Secondary | Safety and tolerability of the investigational treatment | Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up | Assessment according to the latest version of the CTC criteria. In particular due to the expected AE Profile: * Myelosuppressive measures (RBC, PLT units) * Infectious complications * Gastrointestinal problems |
| Secondary | Assessment of the prognostic relevance of International Neuroblastoma Risk Group (INRG) classification system on the event free survival | Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up | |
| Secondary | Prognostic relevance of defined factors on the event free survival in this patient population (i.e. response assessment of HVA, VMA, NSE) | Response to the investigational treatment after 4 courses and 8 courses of I/T and 1-year-follow-up |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38936379 | DERIVED |
Source PubMed
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/NCT01467986
GET https://conductscience.org/api/trials/v1/NCT01467986/registered