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Neuroblastoma

A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy

Unique Dataset IDnci-data-426ClinicalTrial.gov IDNCT01041638
DownloadableNo
SponsorNational Cancer Institute (NCI)Data ProviderNational Cancer InstituteTotal Study Enrolled Patients105RandomizationNoPubMed (PMID)29967609.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeN/ADataset TypeOther

Clinical Trial Title

A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy

Trial Summary and Conditions

This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.

Data Summary

See Data Dictionary.

Study Objectives

Primary: To comprehensively define the safety profile of ch14.18 when administered with cytokines and isotretinoin in high-risk neuroblastoma patients after autologous stem cell transplant (ASCT). Secondary: To further describe and refine the event-free survival (EFS) and overall survival (OS) estimates and baseline characteristics for subjects receiving chl4.18 + cytokines + isotretinoin; To further describe the safety and toxicity of chl4.18 + cytokines + isotretinoin with focus on: a) number of courses delivered per patient; b) number of dose reductions or stoppage (ch14.18 and/or interleukin [IL]-2 [aldesleukin]); and c) number of toxic deaths; To further describe the immune reconstitution of patients following ASCT, based on laboratory data obtained just prior to, during, and after treatment with this regimen; To obtain correlative laboratory data to evaluate and describe mechanisms related to response, toxicity of immune activation, and allergic phenomena.

Outcome Measures

Primary: Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever). [ Time Frame: Up to 5 years] Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported. Secondary: Event-free Survival (EFS) [Time Frame: From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 3 years] Event-free Survival (EFS) for all eligible patients enrolled on the study ;Overall Survival (OS) [ Time Frame: From enrollment until death, or until last contact with the patient, up to 3 years] Overall Sur

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

The data and analysis for the results reported in Table 6 in the paper published was completed externally. Given the limited access to the original data, Table 6 subsequently has not been able to be replicated. There is one row for each patient enrolled on ANBL0931. The dataset provides the information necessary to reproduce patient baseline characteristics, disease outcome, and survival for patients on ANBL0931.

Available Downloads: NCT01041638-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01041638-D1-Data-Dictionary_5.pdf

DATA: NCT01041638-D1-Dataset.CSV

OTHER: README.pdf

Available Downloads: NCT01041638-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01041638-D2-Data-Dictionary_3.pdf

DATA: NCT01041638-D2-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT01041638-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01041638-D3-Data-Dictionary_3.pdf

DATA: NCT01041638-D3-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT01041638-D4

To gain access to the data and analytic tools click here.

Data Dictionary: NCT01041638-D4-Data-Dictionary_3.pdf

DATA: NCT01041638-D4-Dataset_4.csv

OTHER: README.pdf