Gender
All
Age Group
30 Years and under
Accepting Healthy Volunteers
No
Inclusion Criteria:
- Patients must have a diagnosis of neuroblastoma (International Classification of
Diseases for Oncology [ICD-O] morphology 9500/3) or ganglioneuroblastoma (nodular or
intermixed) verified by histology or demonstration of clumps of tumor cells in bone
marrow with elevated urinary catecholamine metabolites; patients with the following
disease stages at diagnosis are eligible, if they meet the other specified criteria
- Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging
System (INSS) stage 4 are eligible with the following:
- V-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN)
amplification (> 4-fold increase in MYCN signals as compared to reference
signals), regardless of age or additional biologic features or
- Age > 18 months (> 547 days) regardless of biologic features or
- Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic
features (MYCN amplification, unfavorable pathology and/or deoxyribonucleic acid
[DNA] index = 1) or any biologic feature that is
indeterminate/unsatisfactory/unknown
- Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the
following:
- MYCN amplification (> 4-fold increase in MYCN signals as compared to reference
signals), regardless of age or additional biologic features or
- Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN
status
- Patients with newly diagnosed neuroblastoma with INSS stage 2A/2B with MYCN
amplification (> 4-fold increase in MYCN signals as compared to reference signals),
regardless of age or additional biologic features
- Patients with newly diagnosed neuroblastoma with INSS stage 4S with MYCN amplification
(> 4-fold increase in MYCN expression signals as compared to reference signals),
regardless of additional biologic features
- Patients >= 365 days initially diagnosed with neuroblastoma INSS stage 1, 2, 4S who
progressed to a stage 4 without interval chemotherapy; these patients must have been
enrolled on ANBL00B1; study enrollment on ANBL12P1 must occur within 4 weeks of
progression to stage 4 for INSS stage 1, 2, 4S
- Patients must not have had prior systemic therapy except for localized emergency
radiation to sites of life-threatening or function-threatening disease and/or no more
than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as
per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification
status and histology
- 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:
- Age 1 month to < 6 months: 0.4 mg/dL
- Age 6 months to < 1 year: 0.5 mg/dL
- Age 1 to < 2 years: 0.6 mg/dL
- Age 2 to < 6 years: 0.8 mg/dL
- Age 6 to < 10 years: 1 mg/dL
- Age 10 to < 13 years: 1.2 mg/dL
- Age 13 to < 16 years: 1.5 mg/dL (males), 1.4 mg/dL (females)
- Age >= 16 years: 1.7 mg/dL (males), 1.4 mg/dL (females)
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x
ULN for age
- Shortening fraction of >= 27% by echocardiogram, or
- Ejection fraction of >= 50% by radionuclide evaluation
- No known contraindication to peripheral blood stem cell (PBSC) collection; examples of
contraindications might be a weight or size less than that determined to be feasible
at the collecting institution, or a physical condition that would limit the ability of
the child to undergo apheresis catheter placement (if necessary) and/or the apheresis
procedure
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic
features (ie, nonamplified MYCN, favorable pathology, and DNA index > 1) are not
eligible
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed their
infants
- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation