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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00567567
Registration number
NCT00567567
Ethics application status
Date submitted
4/12/2007
Date registered
5/12/2007
Date last updated
28/04/2022
Titles & IDs
Public title
Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
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Scientific title
Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma
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Secondary ID [1]
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NCI-2009-01065
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Secondary ID [2]
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ANBL0532
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Localized Resectable Neuroblastoma
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Localized Unresectable Neuroblastoma
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Recurrent Neuroblastoma
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Regional Neuroblastoma
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Stage 4 Neuroblastoma
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Stage 4S Neuroblastoma
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Children's - Other
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Autologous Hematopoietic Stem Cell Transplantation
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Etoposide
Treatment: Other - External Beam Radiation Therapy
Treatment: Other - Filgrastim
Treatment: Drugs - Isotretinoin
Other interventions - Laboratory Biomarker Analysis
Treatment: Drugs - Melphalan
Treatment: Surgery - Peripheral Blood Stem Cell Transplantation
Other interventions - Pharmacological Study
Treatment: Drugs - Thiotepa
Treatment: Drugs - Topotecan Hydrochloride
Treatment: Drugs - Vincristine Sulfate Liposome
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.
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.
Treatment: Surgery: Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplant
Treatment: Drugs: Carboplatin
Given IV
Treatment: Drugs: Cisplatin
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Other: External Beam Radiation Therapy
Undergo EBRT
Treatment: Other: Filgrastim
Given IV or SC
Treatment: Drugs: Isotretinoin
Given orally
Other interventions: Laboratory Biomarker Analysis
Correlative studies
Treatment: Drugs: Melphalan
Given IV
Treatment: Surgery: Peripheral Blood Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplant
Other interventions: Pharmacological Study
Correlative studies
Treatment: Drugs: Thiotepa
Given IV
Treatment: Drugs: Topotecan Hydrochloride
Given IV
Treatment: Drugs: Vincristine Sulfate Liposome
Given IV
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Treatment: Other
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Intervention code [4]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event-free Survival Rate
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Assessment method [1]
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Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)
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Timepoint [1]
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Three years, from time of randomization
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Primary outcome [2]
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Response After Induction Therapy
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Assessment method [2]
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Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \>50%. Mixed Response (MR)-\>50% reduction of any measurable lesion (primary or metastases) with \<50% reduction in other sites; no new lesions; \<25% increase in any existing lesion. No Response (NR)-no new lesions; \<50% reduction but \<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \>25%; previous negative marrow positive.
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Timepoint [2]
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Study enrollment to the end of induction therapy
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Primary outcome [3]
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Incidence Rate of Local Recurrence
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Assessment method [3]
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Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [1]
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Duration of Greater Than or Equal to Grade 3 Neutropenia
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Assessment method [1]
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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.
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Timepoint [1]
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Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days
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Secondary outcome [2]
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Duration of Greater Than or Equal to Grade 3 Thrombocytopenia
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Assessment method [2]
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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.
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Timepoint [2]
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Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days
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Secondary outcome [3]
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Proportion of Patients With a Polymorphism
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Assessment method [3]
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A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.
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Timepoint [3]
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Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days
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Secondary outcome [4]
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Surgical Response
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Assessment method [4]
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Percentage of patients who achieved a surgical complete resection
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Type of Surgical or Radiotherapy Complication
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Assessment method [5]
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The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea.
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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Intraspinal Extension
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Assessment method [6]
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Percentage of patients with primary tumors with intraspinal extension.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
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Assessment method [7]
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Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532
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Timepoint [7]
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Day 1 of each course
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Secondary outcome [8]
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Pharmacogenetic Variants in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies
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Assessment method [8]
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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.
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Timepoint [8]
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At baseline
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Secondary outcome [9]
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Topotecan Systemic Clearance
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Assessment method [9]
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Median topotecan systemic clearance for courses 1 and 2.
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Timepoint [9]
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Day 1 of courses 1-2
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Secondary outcome [10]
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Presence and Function of T Cells Capable of Recognizing Neuroblastoma
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Assessment method [10]
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Timepoint [10]
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Up to 6 months (end of therapy)
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Secondary outcome [11]
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Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells
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Assessment method [11]
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A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed.
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Timepoint [11]
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Up to 6 months after completion of assigned myeloablation therapy
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Secondary outcome [12]
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Proportion of Patients With Neuroblastoma Detected in Bone Marrow and Peripheral Blood Using RT-PCR Technique
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Assessment method [12]
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Will be calculated overall and by treatment arm.
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Timepoint [12]
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Baseline
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Secondary outcome [13]
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EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).
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Assessment method [13]
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Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated.
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Timepoint [13]
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Up to 3 years
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Secondary outcome [14]
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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
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Assessment method [14]
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Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated.
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Timepoint [14]
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Up to 3 years
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
30
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/11/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/03/2022
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Sample size
Target
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Accrual to date
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Final
665
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Royal Brisbane and Women's Hospital - Herston
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Royal Children's Hospital-Brisbane - Herston
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Princess Margaret Hospital for Children - Perth
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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6008 - Perth
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Recruitment outside Australia
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Alabama
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Bern
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00567567
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Trial related presentations / publications
Liu KX, Naranjo A, Zhang FF, DuBois SG, Braunstein SE, Voss SD, Khanna G, London WB, Doski JJ, Geiger JD, Kreissman SG, Grupp SA, Diller LR, Park JR, Haas-Kogan DA. Prospective Evaluation of Radiation Dose Escalation in Patients With High-Risk Neuroblastoma and Gross Residual Disease After Surgery: A Report From the Children's Oncology Group ANBL0532 Study. J Clin Oncol. 2020 Aug 20;38(24):2741-2752. doi: 10.1200/JCO.19.03316. Epub 2020 Jun 12. Park JR, Kreissman SG, London WB, Naranjo A, Cohn SL, Hogarty MD, Tenney SC, Haas-Kogan D, Shaw PJ, Kraveka JM, Roberts SS, Geiger JD, Doski JJ, Voss SD, Maris JM, Grupp SA, Diller L. Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial. JAMA. 2019 Aug 27;322(8):746-755. doi: 10.1001/jama.2019.11642.
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Public notes
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Contacts
Principal investigator
Name
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Julie R Park
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Address
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Children's Oncology Group
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/67/NCT00567567/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/67/NCT00567567/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00567567
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