ANBL09P1, A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma

Summary

induction Therapy Cycles 1 and 2 ----[Greater Than] Stem Cell Collection ----[Greater Than] induction Therapy Cycles 3 and 4 ----[Greater Than] Surgery to Remove Tumor ----[Greater Than] induction Therapy Cycle 5

(after Cycle 5 of induction) if the subject's tumor grows or spreads during treatment, the subject will receive no more treatment on study.

(after Cycle 5 of induction) if the subject's disease stays the same or gets better----[Greater Than] MiBG Therapy* (at MiBG treatment center) ----[Greater Than] Consolidation Therapy ----[Greater Than] autologous Stem Cell Rescue ----[Greater Than] Rest Period (at least 6 weeks) ----[Greater Than] Standard Radiation Therapy ----[Greater Than] Maintenance Therapy (6 cycles) ----[Greater Than] end of Therapy

Those subjects who qualify to receive MiBG treatment will travel to the approved treatment site. none of the participants will receive MiBG treatment at this site. This site is participating only in [Quote]induction, Consolidation and Maintenance Therapy[Quote].

Participant Eligibility

-Patients must be >= 365 days and <= 30 years of age at the time of initial diagnosis.
-Patients have a diagnosis of neuroblastoma (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 newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following:
a. MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals) and age >= 365 days regardless of additional biologic features.
b. Age > 18 months (> 547 days) regardless of biologic features.
c. Age 12-18 months (365-547 days) with any of the following 3 unfavorable biologic features (MYCN amplification, unfavorable pathology and/or 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:
a. MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), and age >= 365 days, regardless of additional biologic features.
b. 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 lifethreatening 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.
- Adequate renal, liver and cardiac function
- Ability to tolerate PBSC collection