Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin
Condition: Ganglioneuroblastoma; Localized Resectable Neuroblastoma; Localized Unresectable Neuroblastoma; Regional Neuroblastoma; Stage 4 Neuroblastoma; Stage 4S Neuroblastoma
MeSH terms: Neuroblastoma; Ganglioneuroblastoma
Intervention: 3-Dimensional Conformal Radiation Therapy; Autologous Hematopoietic Stem Cell Transplantation; Busulfan; Cisplatin; Cyclophosphamide; Doxorubicin Hydrochloride; Etoposide Phosphate; External Beam Radiation Therapy; In Vitro-Treated Peripheral Blood Stem Cell Transplantation; Intensity-Modulated Radiation Therapy; Iobenguane I-131; Isotretinoin; Laboratory Biomarker Analysis; Melphalan; Pharmacological Study; Questionnaire Administration; Therapeutic Conventional Surgery; Topotecan Hydrochloride; Vincristine Sulfate
Intervention description: Undergo radiotherapy; Undergo autologous in vitro-treated peripheral blood stem cell transplantation; Given IV; Given IV; Given IV; Given IV; Given IV; Undergo radiotherapy; Undergo autologous in vitro-treated peripheral blood stem cell transplantation; Undergo radiotherapy; Given IV; Given PO; Correlative studies; Given IV; Correlative studies; Ancillary studies; Undergo surgery; Given IV; Given IV
Intervention MeSH terms: Vitamin A; Cyclophosphamide; Melphalan; Busulfan; Mechlorethamine; Nitrogen Mustard Compounds; Cisplatin; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine; Topotecan; Tretinoin; Etoposide phosphate; 3-Iodobenzylguanidine; Isotretinoin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 1 Year
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This pilot clinical trial studies induction therapy followed by iobenguane I 131 and
      chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing
      stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin.
      Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells.
      Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and
      melphalan, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. A peripheral stem cell transplant may be able to
      replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving
      radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor
      cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have a diagnosis of neuroblastoma (International Classification of Diseases
             for Oncology [ICD-O] morphology 9500/3) or ganglioneuroblastoma 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 myelocytomatosis viral related oncogene, neuroblastoma derived (avian)
                       (MYCN) amplification (> 4-fold increase in MYCN signals as compared to
                       reference signals) and age >= 365 days regardless of additional biologic
                       features

                    -  Age > 18 months (> 547 days) regardless of biologic features

                    -  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
                       indeterminant/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), and age >= 365 days, regardless of additional biologic
                       features

                    -  Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN
                       status

               -  Patients with newly diagnosed INSS stage 2a/2b with MYCN amplification (> 4-fold
                  increase in MYCN signals as compared to reference signals) and age >= 365 days,
                  regardless of additional biologic features

               -  Patients >= 365 days initially diagnosed with: INSS stage 1, 2, 4S who progressed
                  to a stage 4 without interval chemotherapy; these patients must have been
                  enrolled on ANBL00B1; it is to be noted that study enrollment must occur within 4
                  weeks of progression to stage 4 for INSS stage 1, 2, 4S

          -  Patients must have had no 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 low- or intermediate-risk neuroblastoma therapy
             (P9641, A3961, ANBL0531) prior to determination of MYCN amplification and histology

          -  Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
             mL/min/1.73 m^2 OR serum creatinine based on age and/or gender as follows:

               -  =< 0.6 mg/dL (1 to < 2 years of age)

               -  =< 0.8 mg/dL (2 to < 6 years of age)

               -  =< 1.0 mg/dL (6 to < 10 years of age)

               -  =< 1.2 mg/dL (10 to < 13 years of age)

               -  =< 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

               -  =< 1.7 mg/dL (male) or 1.4 mg/dL (female) ( >= 16 years of age)

          -  Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
             serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 10 x
             ULN for age

          -  Shortening fraction >= 27% by echocardiogram or

          -  Ejection fraction >= 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 the collecting institution finds
             feasible, 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:

          -  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

          -  Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic
             features (i.e., non-amplified MYCN, favorable pathology, and DNA index > 1) are not
             eligible

          -  Patients are not eligible if they have received local radiation which includes any of
             the following: 1200 centigray (cGy) to more than 33% of both kidneys (patient must
             have at least 1 kidney that has not exceeded the dose/volume of radiation listed) or
             1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver; emergency
             local irradiation is allowed prior to study entry, provided the patient still meets
             eligibility criteria