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NCT00026312 · CITED IN SOURCE DOCUMENTS

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2026-03-05

This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Event-Free Survival (EFS)

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outcome · POSTED

Event-Free Survival (EFS)

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outcome · POSTED

Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial

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outcome · POSTED

Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0

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outcome · POSTED

Number of Courses of Therapy Delivered

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial

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outcome · NOT POSTED

Average Level of HACA

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outcome · NOT POSTED

Cardiac Repolarization

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outcome · NOT POSTED

Change in MRD

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outcome · NOT POSTED

Change in Tumor Biology

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outcome · NOT POSTED

Circulating B7-H6 Levels

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outcome · NOT POSTED

Genotype of FcR

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outcome · NOT POSTED

Genotype of Kir/Kir-ligand

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outcome · NOT POSTED

Isotretinoin Pharmacokinetic Parameters

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outcome · NOT POSTED

Levels of ADCC

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outcome · NOT POSTED

NKp30 Isoform Expression and SNP

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outcome · NOT POSTED

Presence of Naturally Occurring Anti-glycan Antibodies

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * All patients must be diagnosed with neuroblastoma, and categorized as high risk at the time of diagnosis; exception: patients who are initially diagnosed as non-high-risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma are also eligible * All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include: * Following treatment per A3973 protocol * Following treatment per Pediatric Oncology Group (POG)-9341/9342 protocol * Following treatment per CCG3891 * Following treatment on New Approaches to Neuroblastoma Therapy (NANT) 2001-02 * Enrollment on or following treatment per ANBL02P1 * Enrollment on or following treatment per ANBL07P1 * Tandem transplant patients are eligible: * Following treatment on or per ANBL0532 * Following treatment per POG 9640 * Following treatment per COG ANBL00P1 * Following treatment per CHP 594/Dana-Farber Cancer Institute (DFCI) 34-DAT * No more than 12 months from the date of starting the first induction chemotherapy after diagnosis to the date of ASCT except for the rare occasions as noted below; for tandem ASCT patients, this will be the date of the FIRST stem cell infusion; exception: for those who are initially diagnosed as non-high risk neuroblastoma, but later converted (and/or relapsed) to high risk neuroblastoma, the 12 months restriction should start from the date of induction therapy for high risk neuroblastoma (not from the initial induction therapy for non-high risk disease), to the date of ASCT * At pre-ASCT evaluation patients must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases and bone metastases; patients who meet those criteria must also meet the protocol specified criteria for bone marrow response as outlined below: * =\< 10% tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy * Patient who have no tumor seen on the prior bone marrow, and then have =\< 10% tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible (note that per INRC this would have been defined as "overall" response of progressive disease \[PD\]) * Prior to enrollment on ANBL0032, a determination of mandatory disease staging must be performed (tumor imaging studies including computed tomography \[CT\] or magnetic resonance imaging \[MRI\], MIBG scan, and vanillylmandelic acid \[VMA\]/homovanillic acid \[HVA\]; bone marrow aspirates are required but biopsy may be omitted if negative prior to ASCT); this disease assessment is required for eligibility and should be done preferably within 2 weeks, but must be done within a maximum of 4 weeks before enrollment * For those with residual disease before radiotherapy, re-evaluation of irradiated residual tumors is preferably performed at the earliest 5 days after completing radiotherapy; patients with residual disease are eligible; biopsy is not required; patients who have biopsy proven residual disease after ASCT will be enrolled on Stratum 07 * Patients must not have progressive disease at the time of study enrollment except for protocol specified bone marrow response and except for elevations of catecholamines as the only sign of disease in a patient who had normal catecholamines at pre-ASCT evaluation * Patients must be enrolled before treatment begins; the date protocol therapy is projected to start must be no later than ten (10) calendar days after the date of study enrollment; patients should be enrolled preferably between day 56 and day 85 after peripheral blood stem cell (PBSC) infusion (day from 2nd stem cell infusion for tandem transplant); patients must be enrolled no later than day 200 after PBSC infusion; enrollment must occur after completion of radiotherapy, and after completion of tumor assessment post-ASCT and radiotherapy; informed consent should be obtained within 3 weeks pre-ASCT up to the time of registration * Patients must not have received prior anti-disialoganglioside (GD2) antibody therapy * Patients must have a Lansky or Karnofsky performance scale score of \>= 50% and patients must have a life expectancy of \>= 2 months * Total absolute phagocyte count (APC = %neutrophils + %monocytes) X white blood cell (WBC) is at least 1000/uL * Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows: * No greater than 0.4 mg/dL (1 month to \< 6 months) * No greater than 0.5 mg/dL (6 months to \< 1 year) * No greater than 0.6 mg/dL (1 to \< 2 years) * No greater than 0.8 mg/dL (2 to \< 6 years) * No greater than 1.0 mg/dL (6 to \< 10 years) * No greater than 1.2 mg/dL (10 to \< 13 years) * No greater than 1.4 mg/dL (\>= 13 years \[female\]) * No greater than 1.5 mg/dL (13 to \< 16 years \[male\]) * No greater than 1.7 mg/dL (\>= 16 years \[male\]) * Total bilirubin =\< 1.5 x normal * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 5 x normal * Veno-occlusive disease, if present, should be stable or improving * Shortening fraction of \>= 27% by echocardiogram, or if shortening fraction abnormal, ejection fraction of \>= 55% by gated radionuclide study or echocardiogram; note: the echocardiogram or gated radionuclide study must be performed within 4 weeks prior to enrollment * Forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) \> 60% predicted by pulmonary function test; for children who are unable to do pulmonary function tests (PFTs), no evidence of dyspnea at rest and no exercise intolerance should be documented; note: the pulmonary function test must be performed within 4 weeks prior to enrollment * Patients with seizure disorder may be enrolled if on anticonvulsants and well-controlled; central nervous system (CNS) toxicity \< grade 2 * Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from parent or legal guardian * Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method; female patients who are lactating must agree to stop breast-feeding
healthy Volunteers
false
maximum Age
30 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive isotretinoin PO BID for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy.
    intervention Names
    1. Drug: Isotretinoin
    2. Other: Laboratory Biomarker Analysis
    3. Other: Pharmacological Study
    4. Other: Quality-of-Life Assessment
    label
    Arm I (isotretinoin) (closed to accrual as of 4/16/2009)
    type
    ACTIVE_COMPARATOR
  2. description
    Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive immunotherapy comprising sargramostim SC or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy.
    intervention Names
    1. Biological: Aldesleukin
    2. Biological: Dinutuximab
    3. Drug: Isotretinoin
    4. Other: Laboratory Biomarker Analysis
    5. Other: Pharmacological Study
    6. Other: Quality-of-Life Assessment
    7. Biological: Sargramostim
    label
    Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    description
    Given IV
    name
    Aldesleukin
    other Names
    1. 125-L-Serine-2-133-interleukin 2
    2. Proleukin
    3. r-serHuIL-2
    4. Recombinant Human IL-2
    5. Recombinant Human Interleukin-2
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    description
    Given IV
    name
    Dinutuximab
    other Names
    1. Ch 14.18UTC
    2. Ch14.18
    3. Dinutuximab Beta
    4. MOAB Ch14.18
    5. monoclonal antibody Ch14.18
    6. Qarziba
    7. Unituxin
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Arm I (isotretinoin) (closed to accrual as of 4/16/2009)
    2. Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    description
    Given PO
    name
    Isotretinoin
    other Names
    1. 13-cis retinoic acid
    2. 13-cis-Retinoate
    3. 13-cis-Retinoic Acid
    4. 13-cis-Vitamin A Acid
    5. 13-cRA
    6. Absorica
    7. Accure
    8. Accutane
    9. Amnesteem
    10. cis-Retinoic Acid
    11. Cistane
    12. Claravis
    type
    DRUG
  4. arm Group Labels
    1. Arm I (isotretinoin) (closed to accrual as of 4/16/2009)
    2. Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  5. arm Group Labels
    1. Arm I (isotretinoin) (closed to accrual as of 4/16/2009)
    2. Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    description
    Correlative studies
    name
    Pharmacological Study
    type
    OTHER
  6. arm Group Labels
    1. Arm I (isotretinoin) (closed to accrual as of 4/16/2009)
    2. Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    description
    Ancillary studies
    name
    Quality-of-Life Assessment
    other Names
    1. Quality of Life Assessment
    type
    OTHER
  7. arm Group Labels
    1. Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)
    description
    Given IV or SC
    name
    Sargramostim
    other Names
    1. 23-L-Leucinecolony-Stimulating Factor 2
    2. DRG-0012
    3. Leukine
    4. Prokine
    5. rhu GM-CFS
    6. Sagramostim
    7. Sargramostatin
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1449
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    The average level of HACA at each collection time point during immunotherapy will be calculated.
    measure
    Average Level of HACA
    time Frame
    Up to 10 years
  2. description
    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.
    measure
    Cardiac Repolarization
    time Frame
    Up to 10 years
  3. description
    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.
    measure
    Change in MRD
    time Frame
    Baseline to up to 10 years
  4. description
    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.
    measure
    Change in Tumor Biology
    time Frame
    Baseline to up to 10 years
  5. description
    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.
    measure
    Circulating B7-H6 Levels
    time Frame
    1 week before first sargramostim injection (day -1 of course 1)
  6. description
    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.
    measure
    Genotype of FcR
    time Frame
    Up to 10 years
  7. description
    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.
    measure
    Genotype of Kir/Kir-ligand
    time Frame
    Up to 10 years
  8. description
    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.
    measure
    Isotretinoin Pharmacokinetic Parameters
    time Frame
    At 4 hours after administration on day 14 of course 1
  9. description
    Will be descriptively compared.
    measure
    Levels of ADCC
    time Frame
    Up to 10 years
  10. description
    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.
    measure
    NKp30 Isoform Expression and SNP
    time Frame
    1 week before first sargramostim injection (day -1 of course 1)
  11. description
    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.
    measure
    Presence of Naturally Occurring Anti-glycan Antibodies
    time Frame
    Up to 10 years
primary Outcomes
  1. description
    Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only
    measure
    Event-Free Survival (EFS)
    time Frame
    Three years
secondary Outcomes
  1. description
    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.
    measure
    Event-Free Survival (EFS)
    time Frame
    Three years
  2. description
    EFS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.
    measure
    Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial
    time Frame
    Three years
  3. description
    Proportion of patients experiencing at least one Grade 3 or higher toxicity.
    measure
    Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0
    time Frame
    From enrollment to follow-up
  4. description
    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.
    measure
    Number of Courses of Therapy Delivered
    time Frame
    Courses 1-6
  5. description
    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.
    measure
    Overall Survival (OS)
    time Frame
    Three years
  6. description
    OS for patients receiving RA + Immunotherapy following the cessation of the randomized portion of the study.
    measure
    Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial
    time Frame
    Three years
Full study description
brief Summary
This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
detailed Description
PRIMARY OBJECTIVES: I. Determine if monoclonal antibody Ch14.18 (dinutuximab) + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-autologous stem cell transplant (ASCT) response of complete response (CR), very good partial response (VGPR), or partial response (PR). SECONDARY OBJECTIVES: I. Determine if monoclonal antibody Ch14.18 + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves overall survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. II. Determine if immunotherapy + RA improves event free survival and overall survival as compared to RA alone, in the subgroup of high risk International Neuroblastoma Staging System (INSS) stage 4 neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. III. Determine the toxicities of the combination of monoclonal antibody Ch14.18 with cytokines. IV. To compare the outcome data of the patients with persistent disease documented by biopsy (Stratum 07) to the historical data for the analogous patients from Children's Cancer Group (CCG)-3981. V. To further describe and refine the event free survival (EFS) and overall survival (OS) estimates and baseline characteristics for subjects receiving Ch14.18 + cytokines + RA, following cessation of the randomized portion of the study. VI. To further describe the safety and toxicity of Ch14.18 + cytokines + RA under the new administration guidelines implemented following cessation of the randomized portion of the study with focus on: a) number of courses delivered per subject; b) number of dose reductions or stoppage (ch14.18 and/or interleukin \[IL\]-2); and c) number of toxic deaths. TERTIARY OBJECTIVES: I. In the subgroup of neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR, determine if there is a difference between the two randomized regimens in reducing the minimal residual disease (MRD) burden as detected by the following parameters: meta-iodobenylguanidine (MIBG) scan, immunocytology (IC) of blood and bone marrow samples, reverse transcriptase-polymerase chain reaction (RT-PCR) for tyrosine hydroxylase, phosphoglycolate phosphatase (PGP) 9.5, and melanoma antigen family A, 1 (MAGE-1) in blood and bone marrow. II. Determine if change from baseline of MRD is associated with event free and overall survival. III. Determine whether tumor biology at diagnosis correlates with event-free and overall survival, for either of the randomized regimens. IV. To explore the relationship between antibody-dependent cellular cytoxicity (ADCC) and EFS. V. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy. VI. To determine the variability of 13-cis-retinoic-acid pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity. VII. To determine the potential effect of ch14.18 on cardiac repolarization and to evaluate ch14.18 plasma levels. VIII. To determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions and blood levels of ch14.18. IX. To determine if the genotype of Fc receptor (FcR) and killer cell immunoglobulin-like receptor (Kir)/Kir-ligand correlate with EFS. X. To determine if natural killer cell p30-related protein (NKp30) isoform expression and single nucleotide polymorphism (SNP), and circulating ligand B7-H6 are prognostic of EFS or OS. OUTLINE: Patients stratified with biopsy-confirmed post-ASCT persistent disease who are also enrolled on Children's Oncology Group (COG)-A3973 or COG-ANBL0532 are assigned to treatment Arm II. Patients in the first set of strata are randomized to 1 of 2 treatment arms. ARM I: Beginning on day 56-85 post-ASCT, patients receive isotretinoin orally (PO) twice daily (BID) for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy. (closed to accrual as of 4/16/2009) ARM II: Beginning on day 56-85 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or intravenously (IV) over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy. After completion of study treatment, patients are followed up periodically for 10 years.
Source references
references
  1. citation
    Oesterheld J, Ferguson W, Kraveka JM, Bergendahl G, Clinch T, Lorenzi E, Berry D, Wada RK, Isakoff MS, Eslin DE, Brown VI, Roberts W, Zage P, Harrod VL, Mitchell DS, Hanson D, Saulnier Sholler GL. Eflornithine as Postimmunotherapy Maintenance in High-Risk Neuroblastoma: Externally Controlled, Propensity Score-Matched Survival Outcome Comparisons. J Clin Oncol. 2024 Jan 1;42(1):90-102. doi: 10.1200/JCO.22.02875. Epub 2023 Oct 26.
    pmid
    37883734
    type
    DERIVED
  2. citation
    Desai AV, Gilman AL, Ozkaynak MF, Naranjo A, London WB, Tenney SC, Diccianni M, Hank JA, Parisi MT, Shulkin BL, Smith M, Moscow JA, Shimada H, Matthay KK, Cohn SL, Maris JM, Bagatell R, Sondel PM, Park JR, Yu AL. Outcomes Following GD2-Directed Postconsolidation Therapy for Neuroblastoma After Cessation of Random Assignment on ANBL0032: A Report From the Children's Oncology Group. J Clin Oncol. 2022 Dec 10;40(35):4107-4118. doi: 10.1200/JCO.21.02478. Epub 2022 Jul 15.
    pmid
    35839426
    type
    DERIVED
  3. citation
    Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, Smith M, Anderson B, Villablanca JG, Matthay KK, Shimada H, Grupp SA, Seeger R, Reynolds CP, Buxton A, Reisfeld RA, Gillies SD, Cohn SL, Maris JM, Sondel PM; Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1324-34. doi: 10.1056/NEJMoa0911123.
    pmid
    20879881
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        ere treated with chemotherapy alone and those who were treated with autologous HSCT.</li></ul></div></li><li>In a COG phase III trial (<a href="/clinicaltrials/NCT00026312">ANBL0032 [NCT00026312]</a>), participants who had previously undergone HSCT were randomly assigned to receive dinutuximab administered with GM-CSF and IL-2 in
        end
        410374
        exact text
        NCT00026312
        start
        410363
      2. context exact
        herapy alone and those who were treated with autologous HSCT.</li></ul></div></li><li>In a COG phase III trial (<a href="/clinicaltrials/NCT00026312">ANBL0032 [NCT00026312]</a>), participants who had previously undergone HSCT were randomly assigned to receive dinutuximab administered with GM-CSF and IL-2 in conjunction with isotr
        end
        410397
        exact text
        NCT00026312
        start
        410386
      3. context exact
        tion_8.54">54</a>] This finding was confirmed and expanded by an analysis of outcomes for patients treated in the national randomized <a href="/clinicaltrials/NCT00026312">COG-ANBL0032 (NCT00026312)</a> study with the anti-GD2 antibody dinutuximab combined with GM-CSF and IL-2. The study found that certain KIR/KIR-ligand genotyp
        end
        413648
        exact text
        NCT00026312
        start
        413637
      4. context exact
        nding was confirmed and expanded by an analysis of outcomes for patients treated in the national randomized <a href="/clinicaltrials/NCT00026312">COG-ANBL0032 (NCT00026312)</a> study with the anti-GD2 antibody dinutuximab combined with GM-CSF and IL-2. The study found that certain KIR/KIR-ligand genotypes were associated with bet
        end
        413675
        exact text
        NCT00026312
        start
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      5. context exact
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      1. context
        Updated: April 28, 2025
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        April 28, 2025

    Preserved source evidence · Not medical advice