Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00567567
First received: December 4, 2007
Last updated: April 20, 2015
Last verified: April 2015
  Purpose

This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.


Condition Intervention Phase
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carboplatin
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Drug: Etoposide
Radiation: External Beam Radiation Therapy
Biological: Filgrastim
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
Drug: Thiotepa
Drug: Topotecan Hydrochloride
Drug: Vincristine Sulfate Liposome
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival rate [ Time Frame: From the time of randomization, i.e., just prior to the first transplant, assessed up to 3 years ] [ Designated as safety issue: No ]
    Intent-to-treat log-rank test comparison of EFS curves, starting from the time of randomization, by treatment group (AT-CEM vs. AT1-TC & AT2-CEM). Kaplan-Meier curves will be generated starting from a) the time of randomization (this is the definitive analysis); b) the time of transplant; c) the time of completion of the last transplant (for descriptive purposes); and d) the time of diagnosis (for descriptive purposes).

  • Incidence rate of local recurrence [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Log-rank test to compare the risk for local recurrence within the subset of patients who obtain a pre-transplant primary site < CR, i.e., comparing ANBL0532 patients randomized to get one transplant versus the historical A3973 patients who were randomized to unpurged transplant.

  • Response after induction therapy [ Time Frame: 126 days ] [ Designated as safety issue: No ]
    Chi-square test of proportions in all patients to compare the proportion of responders (complete response [CR]+ very good partial response [VGPR]) at the end of induction in this study to the analogous proportion in A3973. There is no reason to believe that the characteristics of the induction cohort on this study will differ from that of the induction cohort on A3973, so this will be a fair and appropriate comparison.


Secondary Outcome Measures:
  • Duration of greater than or equal to grade 3 neutropenia [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.

  • Duration of greater than or equal to grade 3 thrombocytopenia [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.

  • EFS in patients 12-18 months, stage 4, MYCN nonamplified tumor/unfavorable histopathology/diploid DNA content/indeterminant histology/ploidy and patients > 547 days, stage 3, MYCN nonamplified tumor AND unfavorable histopathology/indeterminant histology [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves of EFS and OS will be plotted, and the proportion of responders to induction therapy will be tabulated.

  • Enumeration of peripheral blood cluster of differentiation (CD)3, CD4, and CD8 cells [ Time Frame: U to 6 months after completion of assigned myeloablation therapy ] [ Designated as safety issue: No ]
    A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed..

  • Neurologic symptom resolution in patients with primary tumors with intraspinal extension [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Descriptive tabulation of the proportion of patients with resolution of neurologic symptoms by type of symptom.

  • OS in patients 12-18 months, stage 4, MYCN nonamplified tumor/unfavorable histopathology/diploid DNA content/indeterminant histology/ploidy and patients > 547 days, stage 3, MYCN nonamplified tumor AND unfavorable histopathology/indeterminant histology [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier curves of EFS and OS will be plotted, and the proportion of responders to induction therapy will be tabulated.

  • Peak serum concentration of isotretinoin in patients enrolled on either A3973, ANBL0032, ANBL0931, ANBL0532 and future high risk studies [ Time Frame: Day 1 of each course ] [ Designated as safety issue: No ]
    To determine the relationship of peak serum concentration level with the existence of polymorphisms, Kendall's Tau statistic will be calculated. To determine if there is a relationship of the peak serum concentration level with event-free survival, 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 (Common Toxicity Criteria [CTC] grade 3 or 4 skin, hypercalcemia, or hepatic toxicity), Kendall's Tau statistic will be calculated.

  • Pharmacogenetic variants in patients enrolled on either A3973, ANBL0032, ANBL0931, ANBL0532 and future high risk studies [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To determine if pharmacogenomic variations are predictive of EFS, a logrank test comparison of patients with vs without a given polymorphism will be made. A Fisher's exact test will test for association of the presence of a polymorphism with the occurrence of systemic toxicity (CTC grade 3 or 4 skin, hypercalcemia, or hepatic toxicity). These tests will be performed for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles.

  • Presence and function of T cells capable of recognizing neuroblastoma [ Time Frame: Up to 6 months (end of therapy) ] [ Designated as safety issue: No ]
  • Proportion of patients with neuroblastoma detected in bone marrow and peripheral blood using RT-PCR technique [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Will be calculated overall and by treatment arm.

  • Response rate [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    A chi-square test of association will be used to compare the proportion of responders with versus without a polymorphism.

  • Surgical response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    A chi-square test of proportions will be used to test for association between the proportion of patients who achieve a surgical CR and the proportion of patients who do not relapse in the primary. A logrank test will compare the EFS curves for degree of surgical response (CR vs. < CR).

  • Topotecan systemic clearance [ Time Frame: Day 1 of courses 1-2 ] [ Designated as safety issue: No ]
    The topotecan total clearance value will be calculated from a single sample using Bayesian modeling techniques and population priors. The relation between the topotecan clearance value determined by pharmacokinetic analysis (limited sampling; Bayesian modeling) and the topotecan clearance value determined by the topotecan dosing model (patient covariates) will be investigated using regression analysis and simulation studies.

  • Type of radiotherapy complication [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    The proportion of patients by type of surgical complication and type of radiation therapy complication will be descriptively tabulated. The complications are: bowel obstruction, chylous leak, renal injury/atrophy/loss and diarrhea.

  • Type of surgical complication [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    The proportion of patients by type of surgical complication and type of radiation therapy complication will be descriptively tabulated. The complications are: bowel obstruction, chylous leak, renal injury/atrophy/loss and diarrhea.


Enrollment: 665
Study Start Date: November 2007
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Consolidation Arm A: single myeloablative consolidation
Patients receive melphalan IV over 15-30 minutes on days -7 to -5, etoposide IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Patients undergo autologous PBSCT on day 0.
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplant
Other Name: Autologous Stem Cell Transplantation
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • CARBOPLATIN
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplat
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • CISPLATIN
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • CYCLOPHOSPHAMIDE
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • DOXORUBICIN HYDROCHLORIDE
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • ETOPOSIDE
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation Therapy
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
Biological: Filgrastim
Given IV or SC
Other Names:
  • FILGRASTIM
  • Filgrastim XM02
  • G-CSF
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • rG-CSF
  • Tbo-filgrastim
  • Tevagrastim
Drug: Isotretinoin
Given orally
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • ISOTRETINOIN
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Melphalan
Given IV
Other Names:
  • Alanine Nitrogen Mustard
  • CB-3025
  • L-PAM
  • L-Phenylalanine Mustard
  • L-Sarcolysin
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • MELPHALAN
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine Nitrogen Mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplant
Other Names:
  • PBPC transplantation
  • Peripheral Blood Progenitor Cell Transplantation
  • Peripheral Stem Cell Support
  • Peripheral Stem Cell Transplantation
Other: Pharmacological Study
Correlative studies
Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • TOPOTECAN HYDROCHLORIDE
  • topotecan hydrochloride (oral)
Drug: Vincristine Sulfate Liposome
Given IV
Other Name: Marqibo
Experimental: Consolidation Arm B: tandem myeloablative consolidation
Patients receive thiotepa IV over 2 hours on days -7 to -5, cyclophosphamide IV over 1 hour on days -5 to -2, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Following clinical recovery from initial myeloablative therapy, patients also receive melphalan, etoposide, and carboplatin as in Arm A. Patients undergo autologous PBSCT on day 0.
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplant
Other Name: Autologous Stem Cell Transplantation
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • CARBOPLATIN
  • Carboplatin Hexal
  • Carboplatino
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplat
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • CISPLATIN
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Cyclophosphamide
Given IV
Other Names:
  • (-)-Cyclophosphamide
  • 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  • Carloxan
  • Ciclofosfamida
  • Ciclofosfamide
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrate
  • CTX
  • CYCLO-cell
  • Cycloblastin
  • Cycloblastine
  • Cyclophospham
  • Cyclophosphamid monohydrate
  • CYCLOPHOSPHAMIDE
  • Cyclophosphamidum
  • Cyclophosphan
  • Cyclophosphane
  • Cyclophosphanum
  • Cyclostin
  • Cyclostine
  • Cytophosphan
  • Cytophosphane
  • Cytoxan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin Hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • DOXORUBICIN HYDROCHLORIDE
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • ETOPOSIDE
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213
Radiation: External Beam Radiation Therapy
Undergo EBRT
Other Names:
  • Definitive Radiation Therapy
  • EBRT
  • External Beam Radiation Therapy
  • External Beam Radiotherapy
  • External Beam RT
  • external radiation
  • External Radiation Therapy
  • external-beam radiation
Biological: Filgrastim
Given IV or SC
Other Names:
  • FILGRASTIM
  • Filgrastim XM02
  • G-CSF
  • Neupogen
  • r-metHuG-CSF
  • Recombinant Methionyl Human Granulocyte Colony Stimulating Factor
  • rG-CSF
  • Tbo-filgrastim
  • Tevagrastim
Drug: Isotretinoin
Given orally
Other Names:
  • 13-cis retinoic acid
  • 13-cis-Retinoate
  • 13-cis-Retinoic Acid
  • 13-cis-Vitamin A Acid
  • 13-cRA
  • Accure
  • Accutane
  • Amnesteem
  • cis-Retinoic Acid
  • Cistane
  • Claravis
  • ISOTRETINOIN
  • Isotretinoinum
  • Isotrex
  • Isotrexin
  • Neovitamin A
  • Neovitamin A Acid
  • Oratane
  • Retinoicacid-13-cis
  • Ro 4-3780
  • Ro-4-3780
  • Roaccutan
  • Roaccutane
  • Roacutan
  • Sotret
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Melphalan
Given IV
Other Names:
  • Alanine Nitrogen Mustard
  • CB-3025
  • L-PAM
  • L-Phenylalanine Mustard
  • L-Sarcolysin
  • L-Sarcolysin Phenylalanine mustard
  • L-Sarcolysine
  • MELPHALAN
  • Melphalanum
  • Phenylalanine Mustard
  • Phenylalanine Nitrogen Mustard
  • Sarcoclorin
  • Sarkolysin
  • WR-19813
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplant
Other Names:
  • PBPC transplantation
  • Peripheral Blood Progenitor Cell Transplantation
  • Peripheral Stem Cell Support
  • Peripheral Stem Cell Transplantation
Other: Pharmacological Study
Correlative studies
Drug: Thiotepa
Given IV
Other Names:
  • 1,1',1''-Phosphinothioylidynetrisaziridine
  • Girostan
  • N,N', N''-Triethylenethiophosphoramide
  • Oncotiotepa
  • STEPA
  • Tepadina
  • TESPA
  • Tespamin
  • Tespamine
  • Thio-Tepa
  • Thiofosfamide
  • Thiofozil
  • Thiophosphamide
  • Thiophosphoramide
  • Thiotef
  • THIOTEPA
  • Tifosyl
  • TIO TEF
  • Tio-tef
  • Triethylene Thiophosphoramide
  • Triethylenethiophosphoramide
  • Tris(1-aziridinyl)phosphine sulfide
  • TSPA
  • WR 45312
Drug: Topotecan Hydrochloride
Given IV
Other Names:
  • Hycamptamine
  • Hycamtin
  • SKF S-104864-A
  • Topotecan HCl
  • TOPOTECAN HYDROCHLORIDE
  • topotecan hydrochloride (oral)
Drug: Vincristine Sulfate Liposome
Given IV
Other Name: Marqibo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by the presence of clumps of tumor cells in bone marrow and elevated catecholamine metabolites in urine meeting any of the following criteria:

    • Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following:

      • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
      • Age > 18 months (i.e., > 547 days) regardless of biologic features
      • Age 12-18 months (i.e., 365-547 days) with none of the following three favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and deoxyribonucleic acid [DNA] index > 1)
    • Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:

      • MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
      • Age > 18 months (i.e., > 547 days) with unfavorable pathology, regardless of MYCN status
    • Patients with newly diagnosed INSS stage 2a or 2b with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features
    • Patients with newly diagnosed INSS stage 4s with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features
    • Patients >= 365 days initially diagnosed with INSS stage 1, 2, or 4S and who progressed to a stage 4 without interval chemotherapy

      • Must have been enrolled on COG-ANBL00B1
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum creatinine based on age/gender as follows:

    • 1 month to < 6 months: 0.4 mg/dL
    • 6 months to < 1 year: 0.5 mg/dL
    • 1 to < 2 years: 0.6 mg/dL
    • 2 to < 6 years: 0.8 mg/dL
    • 6 to < 10 years: 1 mg/dL
    • 10 to < 13 years: 1.2 mg/dL
    • 10 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)
    • >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 10 times ULN for age
  • Not pregnant or nursing
  • Negative pregnancy test
  • Shortening fraction >= 27% by echocardiogram (ECHO) OR left ventricular ejection fraction (LVEF) >= 50% by radionuclide angiogram
  • No known contraindication (e.g., size, weight or physical condition) to peripheral blood stem cell collection
  • No prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease
  • No more than one course of chemotherapy per low- or intermediate-risk neuroblastoma therapy prior to determination of MYCN amplification and histology
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567567

  Show 183 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Julie Park, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00567567     History of Changes
Other Study ID Numbers: ANBL0532, NCI-2009-01065, CDR0000576571, COG-ANBL0532, ANBL0532, ANBL0532, U10CA098543
Study First Received: December 4, 2007
Last Updated: April 20, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Carboplatin
Cisplatin
Cyclophosphamide
Doxorubicin
Etoposide
Etoposide phosphate
Isotretinoin
Lenograstim
Liposomal doxorubicin
Mechlorethamine
Melphalan
Nitrogen Mustard Compounds
Succinylcholine
Thiotepa
Topotecan
Tretinoin
Vincristine
Adjuvants, Immunologic
Alkylating Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 29, 2015