Trial · NCT00026312
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Event-Free Survival (EFS) | Three years | Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only |
| Secondary | Event-Free Survival (EFS) | Three years | Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only for the subgroup of randomized patients with INSS Stage 4 disease. Descriptive comparison of outcome data for patients with persistent disease documented by biopsy to historical data for the analogous patients from CCG-3981. |
| Secondary | Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial | Three years | EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study. |
| Secondary | Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0 | From enrollment to follow-up | Proportion of patients experiencing at least one Grade 3 or higher toxicity. |
| Secondary | Number of Courses of Therapy Delivered | Courses 1-6 | Number of courses of therapy delivered for patients randomized to RA + Immunotherapy vs. patients non-randomly assigned to RA + Immunotherapy, excluding patients with persistent disease. |
| Secondary | Overall Survival (OS) | Three years | Comparison to determine if RA + Immunotherapy improves OS as compared to RA Only. Comparison to determine if RA + Immunotherapy improves OS as compared to RA only and for the subgroup of randomized patients with INSS Stage 4 disease. |
| Secondary | Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial | Three years | OS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study. |
| Other | Average Level of HACA | Up to 10 years | The average level of HACA at each collection time point during immunotherapy will be calculated. |
| Other | Cardiac Repolarization | Up to 10 years | In general, descriptive summaries will include n, mean, standard deviation, median, minimum, maximum and 90% confidence intervals for continuous variables, and n and percent for categorical variables. Summaries will present data by assessment time when appropriate. |
| Other | Change in MRD | Baseline to up to 10 years | A descriptive analysis of the change from baseline of MRD will be performed. Also, a Wilcoxon rank-sum test will be performed to compare the median change from baseline of MRD between the two treatment arms. A multivariate Cox proportional hazards regression model will test to see if the change in MRD burden is associated with EFS or OS. |
| Other | Change in Tumor Biology | Baseline to up to 10 years | A multivariate Cox proportional hazards regression model will test to see if the dinutuximab serum level, HACA titer, effector cell function, or serum marker for effector cell activation are associated with EFS or OS. |
| Other | Circulating B7-H6 Levels | 1 week before first sargramostim injection (day -1 of course 1) | Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of circulating B7-H6 level, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of circulating B7-H6 level, adjusting for significant prognostic factors including MYCN status, INSS stage, histology and age at diagnosis. |
| Other | Genotype of FcR | Up to 10 years | Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand. |
| Other | Genotype of Kir/Kir-ligand | Up to 10 years | Kaplan-Meier plots of EFS will be generated for the three genotype subgroups of FcR as well as for the three genotype subgroups of Kir/Kir-ligand. In addition, a log rank test comparison will be made in a pairwise fashion of each of the genotypes within FcR and within Kir/Kir-ligand. |
| Other | Isotretinoin Pharmacokinetic Parameters | At 4 hours after administration on day 14 of course 1 | To determine if there is a relationship of the peak serum concentration level with EFS, the term for this level will be tested in a Cox proportional hazards model. To determine if there is a relationship of the peak serum concentration level with toxicity rates, Kendall's Tau statistic will be calculated. |
| Other | Levels of ADCC | Up to 10 years | Will be descriptively compared. |
| Other | NKp30 Isoform Expression and SNP | 1 week before first sargramostim injection (day -1 of course 1) | Kaplan-Meier plots of EFS and OS will be generated after dichotomization using the median value for the cohort. To determine the prognostic value of NKp30 isoform expression and SNP, univariate analysis will be performed using a log rank test for EFS and OS. In multivariable analysis of EFS and OS, Cox models will be used to test for the independent prognostic ability of NKp30 isoform expression and SNP, adjusting for significant prognostic factors including v-MYC myelocytomatosis viral related oncogene, neuroblastoma derived (avian) (MYCN) status, INSS stage, histology and age at diagnosis. |
| Other | Presence of Naturally Occurring Anti-glycan Antibodies | Up to 10 years | A Fisher's exact test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions. A Wilcoxon test will be performed to determine if the presence of naturally occurring anti-glycan antibodies correlates with blood levels of dinutuximab. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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