Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-11 @ 11:15 AM
Study NCT ID:
NCT02176967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2014-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018305', 'term': 'Ganglioneuroblastoma'}, {'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D057832', 'term': 'Watchful Waiting'}, {'id': 'D019370', 'term': 'Observation'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 621}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2014-06-26', 'studyFirstSubmitQcDate': '2014-06-26', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to intervention or tumor progression', 'timeFrame': 'Up to 3 years', 'description': 'Will be assessed by a descriptive analysis for the cohort of patients with localized tumors who progress after an initial period of observation.'}, {'measure': 'Type of intervention required', 'timeFrame': 'Up to 3 years', 'description': 'Will be assessed by a descriptive analysis for the cohort of patients with localized tumors who progress after an initial period of observation.'}, {'measure': 'Site of progression', 'timeFrame': 'Up to 3 years', 'description': 'Will be assessed by a descriptive analysis for the cohort of patients with localized tumors who progress after an initial period of observation.'}, {'measure': 'Pharmacokinetic (PK) profile of carboplatin and etoposide in patients with stage Ms disease, including peak concentration, area under the curve, clearance, volume of distribution, half-life, and mean residence time', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours on days 1 and 2 of either course 1 or 7', 'description': "The coefficient of variation will be calculated to quantify the degree of inter-patient and intra-patient variability of etoposide and carboplatin PK. The relationship between patient characteristics will be assessed graphically in an exploratory fashion and with regression models and if appropriate, Spearman's rank correlation coefficient will be used. Correlations between PK parameters and the symptom score and hepatic and renal dysfunction will be explored. Logistic regression models adjusting for patient level covariates will be explored."}, {'measure': 'Genomic profile of tumors', 'timeFrame': 'Up to time of biopsy or surgical resection', 'description': 'Will be assessed by determining the presence or absence of each segmental aberration (segmental loss at 1p, 3p, 4p, or 11q or segmental gain at 1p, 2p, or 17q), both at initial biopsy and at the time of subsequent biopsy or surgical resection, and correlating with patient characteristics using a chi-squared test and with outcome using a log-rank test. In cases with specimens from diagnosis and at the time of subsequent biopsy/resection, the profiles will be compared focusing on changes in the copy number pattern.'}, {'measure': 'Histology of tumor specimens', 'timeFrame': 'Up to time of biopsy or surgical resection', 'description': 'Will be assessed by a descriptive analysis of the histology of tumor specimens obtained at the time of subsequent biopsy or surgical resection.'}, {'measure': 'Salvage rate (overall survival [OS]) of patients with tumor relapse or disease progression', 'timeFrame': 'From the date of enrollment until death or until last contact if the patient is alive, assessed up to 3 years', 'description': 'Will be assessed by calculating the overall survival for the cohort of patients with tumor relapse or disease progression.'}, {'measure': 'Procedural complication rate', 'timeFrame': 'Up to 60 days after surgery', 'description': 'Will be assessed by determining the complication rate for each type of procedure (initial biopsy and resection \\[intraoperative and postoperative\\]) and correlating the occurrence of surgical complications with the degree of surgical resection using a Wilcoxon rank-sum test (to account for the ordering of the surgical resection categories).'}, {'measure': 'Rate of reduction in Image Defined Risk Factors (IDRF) in L2 tumors', 'timeFrame': 'Up to 3 years', 'description': "Will be assessed by computing the proportion of patients with L2 tumors for which each particular IDRF and any IDRF is present at diagnosis and then absent after observation or chemotherapy. In addition, McNemar's test for paired observations will be applied to determine whether there is a difference in the proportion of each IDRF and any IDRF present before and after observation or chemotherapy."}], 'primaryOutcomes': [{'measure': 'Overall survival (OS) (Strata 1-4)', 'timeFrame': 'From date of enrollment until death or last contact, assessed up to 3 years', 'description': 'The Kaplan-Meier method will be used to estimate the 3-year overall survival for each stratum. OS is measured from time of enrollment to the date of death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ganglioneuroblastoma', 'Localized Resectable Neuroblastoma', 'Localized Unresectable Neuroblastoma', 'Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To eliminate therapy as the initial approach for infants \\< 12 months of age with small International Neuroblastoma Risk Group (INRG) stage L1 neuroblastoma while maintaining an overall survival (OS) of 99%.\n\nII. To eliminate therapy as the initial approach for non-high-risk patients \\< 18 months of age with localized neuroblastoma and favorable biology (histologic and genomic features) while maintaining an OS of 99%.\n\nIII. To achieve a 3-year OS of \\> 81% for infants \\< 18 months of age with INRG stage Ms neuroblastoma using objective criteria for early initiation of a response-based treatment algorithm.\n\nEXPLORATORY OBJECTIVES:\n\nI. To describe the time to intervention or tumor progression, type of intervention and site of progression for patients with localized neuroblastoma who experience progression after an initial period of observation.\n\nII. To characterize the pharmacokinetic profile of the chemotherapeutic agents carboplatin and etoposide in patients with stage Ms disease.\n\nIII. To define the genomic profile of tumors from patients with non-high-risk neuroblastoma both at initial biopsy and at the time of subsequent biopsy or surgical resection.\n\nIV. To describe the histology of tumor specimens obtained at the time of subsequent biopsy or surgical resection.\n\nV. To determine the salvage rate (OS) of patients with tumor relapse or disease progression.\n\nVI. To determine the procedural complication rate (initial biopsy, resection \\[intraoperative and postoperative\\], subsequent biopsy) and correlate with the degree of surgical resection.\n\nVII. To determine the rate of reduction in image defined risk factors (IDRF) in L2 tumors following observation or chemotherapy.\n\nOUTLINE: Patients are assigned to 1 of 3 treatment groups.\n\nGROUP A: Patients undergo clinical observation for 96 weeks in the absence disease progression. Patients also undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or ultrasound throughout the trial.\n\nGROUP B: Patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients undergo surgery or receive first-line chemotherapy comprising carboplatin intravenously (IV) over 1 hour on day 1 (courses 1, 2, 4, 6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15 minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a partial response (PR) or better is achieved, patients undergo clinical observation for 3 years. Patients also undergo CT, MRI, and/or ultrasound throughout the trial and undergo bone marrow aspiration, bone marrow biopsy, and tumor biopsy at screening and time of progression.\n\nGROUP C: Patients at high risk for deterioration and a poor outcome immediately receive first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients receive first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo clinical observation for 3 years. Patients also undergo CT, MRI, and/or ultrasound throughout the trial and undergo bone marrow aspiration, bone marrow biopsy, and tumor biopsy at screening and time of progression.\n\nAfter completion of study treatment, patients are followed up annually for up to 10 years post-enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be:\n\n * \\< 12 months (\\< 365 days) of age at diagnosis with INRG stage L1; or\n * \\< 18 months (\\< 547 days) of age at diagnosis with INRG stage L2 or stage Ms neuroblastoma/ganglioneuroblastoma\n* Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients\n* Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology \\[ICD-O\\] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology\n* Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index\n\n * "Favorable" genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index \\> 1) in the absence of segmental chromosome aberrations as defined above\n * "Unfavorable" genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH)\n * Only patients with MYCN non-amplified tumors are eligible for this study\n* Group A: patients \\< 12 months (\\< 365 days) of age with newly diagnosed INRG stage L1 neuroblastoma/ganglioneuroblastoma who meet the following criteria:\n\n * Greatest tumor diameter \\< 5 cm of adrenal or non-adrenal origin\n * Patients with non-adrenal primaries are eligible, but must have positive uptake on metaiodobenzylguanidine (MIBG) scan or elevated catecholamine metabolites (urine or serum) to support the diagnosis of neuroblastoma\n * No prior tumor resection or biopsy\n* Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes\n\n * Group A1:\n\n * \\> 6 months and \\< 12 months of age with an adrenal primary tumor \\< 5 cm in greatest diameter OR\n * Patients less than 6 months of age with an adrenal primary tumor \\> 3.1 and \\< 5 cm in greatest diameter OR\n * \\< 12 months of age with a non-adrenal primary site \\< 5 cm in greatest diameter\n * Group A2: =\\< 6 months of age with an adrenal primary site and tumor =\\< 3.1 cm in greatest diameter\n* Group B: patients \\< 18 months (\\< 547 days) of age with newly diagnosed INRG stage L2 neuroblastoma/ganglioneuroblastoma who meet the following criteria:\n\n * No life threatening symptoms or no impending neurologic or other organ function compromise (e.g. epidural or intraspinal tumors with existing or impending neurologic impairment, periorbital or calvarial-based lesions with existing or impending cranial nerve impairment, anatomic or mechanical compromise of critical organ function by tumor \\[abdominal compartment syndrome, urinary obstruction, etc.\\]); horner syndrome is not considered neurologic compromise\n * No prior tumor resection, tumor biopsy ONLY\n * Only patients with both favorable histology and favorable genomic features will remain on study as part of Group B; the institution will be notified of histologic and genomic results within 3 weeks of specimen submission on ANBL00B1 or APEC14B1\n* Group C: patients \\< 18 months (\\< 547 days) of age with newly diagnosed INRG stage Ms neuroblastoma/ganglioneuroblastoma\n* No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with MYCN amplified tumors are not eligible\n* Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure\n* Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study'}, 'identificationModule': {'nctId': 'NCT02176967', 'briefTitle': 'Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients With Non-High-Risk Neuroblastoma', 'orgStudyIdInfo': {'id': 'ANBL1232'}, 'secondaryIdInfos': [{'id': 'NCI-2014-00677', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 's15-00462'}, {'id': 'ANBL1232', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'ANBL1232', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (clinical observation)', 'description': 'Patients undergo clinical observation for 96 weeks in the absence of disease progression. Patients also undergo CT, MRI, and/or ultrasound throughout the trial.', 'interventionNames': ['Other: Clinical Observation', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Group B (clinical observation, first-line chemotherapy)', 'description': 'Patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients undergo surgery or receive first-line chemotherapy comprising carboplatin IV over 1 hour on day 1 (courses 1, 2, 4, 6, and 7), etoposide IV over 1 hour on days 1-3 (courses 1, 3, 4, 5, and 7), cyclophosphamide IV over 1 hour on day 1 (courses 2, 3, 5, 6, and 8), and doxorubicin hydrochloride IV over 15 minutes on day 1 (courses 2, 4, 6 and 8). Treatment with chemotherapy repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. Once a PR or better is achieved, patients undergo clinical observation for 3 years. Patients also undergo CT, MRI, and/or ultrasound throughout the trial and undergo bone marrow aspiration, bone marrow biopsy, and tumor biopsy at screening and time of progression.', 'interventionNames': ['Procedure: Biopsy', 'Procedure: Bone Marrow Aspiration', 'Procedure: Bone Marrow Biopsy', 'Drug: Carboplatin', 'Other: Clinical Observation', 'Procedure: Computed Tomography', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Ultrasound']}, {'type': 'EXPERIMENTAL', 'label': 'Group C (clinical observation, first-line chemotherapy)', 'description': 'Patients at high risk for deterioration and a poor outcome immediately receive first-line chemotherapy as in Group B. All other patients undergo clinical observation for 3 years in the absence of disease progression. Upon disease progression, patients receive first-line chemotherapy as in Group B. Once a PR or better is achieved, patients undergo clinical observation for 3 years. Patients also undergo CT, MRI, and/or ultrasound throughout the trial and undergo bone marrow aspiration, bone marrow biopsy, and tumor biopsy at screening and time of progression.', 'interventionNames': ['Procedure: Biopsy', 'Procedure: Bone Marrow Aspiration', 'Procedure: Bone Marrow Biopsy', 'Drug: Carboplatin', 'Other: Clinical Observation', 'Procedure: Computed Tomography', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Ultrasound']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'otherNames': ['BIOPSY_TYPE', 'Bx'], 'description': 'Undergo biopsy', 'armGroupLabels': ['Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Bone Marrow Aspiration', 'type': 'PROCEDURE', 'description': 'Undergo bone marrow aspiration', 'armGroupLabels': ['Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Bone Marrow Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Biopsy of Bone Marrow', 'Biopsy, Bone Marrow'], 'description': 'Undergo bone marrow biopsy', 'armGroupLabels': ['Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carboplatinum', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'JM8', 'Nealorin', 'Novoplatinum', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo'], 'description': 'Given IV', 'armGroupLabels': ['Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Clinical Observation', 'type': 'OTHER', 'otherNames': ['observation'], 'description': 'Undergo clinical observation', 'armGroupLabels': ['Group A (clinical observation)', 'Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Group A (clinical observation)', 'Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Asta B 518', 'B 518', 'B-518', 'B518', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR 138719', 'WR- 138719', 'WR-138719', 'WR138719'], 'description': 'Given IV', 'armGroupLabels': ['Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Doxorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['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 HCl', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'FI106', 'hydroxydaunorubicin', 'Rubex'], 'description': 'Given IV', 'armGroupLabels': ['Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16', 'VP 16-213', 'VP 16213', 'VP-16', 'VP-16-213', 'VP-16213', 'VP16', 'VP16213'], 'description': 'Given IV', 'armGroupLabels': ['Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Group A (clinical observation)', 'Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}, {'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'Undergo ultrasound', 'armGroupLabels': ['Group A (clinical observation)', 'Group B (clinical observation, first-line chemotherapy)', 'Group C (clinical observation, first-line chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'USA Health Strada Patient Care Center', 'geoPoint': {'lat': 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