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Protocol No. ANBL1531

Principal Investigator DeSantes, Kenneth

Phase III

Age Group Children

Scope National

Sponsor Type Industry; National

Title A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL)

Objective The purpose of this research study is to see if we can improve the treatment for subjects with high-risk neuroblastoma (NBL) by adding the experimental drug 131I-MIBG or the experimental drug Crizotinib to COG (Children s Oncology Group) recommended therapy. In this part of the study, we want to find out if we can reduce the number of stem cell transplants from two to one if we give the experimental drug 131I-MIBG during Induction, and use different drugs as part of the transplant chemotherapy given prior to stem cell infusion during Consolidation

Treatment Arm A treatment COG recommended therapy (not experimental)
Arm B treatment COG recommended therapy + 131I-MIBG during Induction (experimental)
Arm C treatment COG recommended therapy + 131I-MIBG during Induction and single stem cell transplant with BuMel (Busulfan and Melphalan) during Consolidation (experimental)

Key Eligibility
  • Both boys and girls of all races and ethnic groups are eligible for this study
  • Patients must be enrolled on ANBL00B1 or APEC14B1 prior to enrollment on ANBL1531
  • Patient must be ≥ 365 days and ≤ 30 years of age
  • Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular) verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
  • Adequate renal, liver and cardiac function
  • Ability to tolerate PBSC Collection
  • Patients who have an INRG Stage L2 tumor without amplification of MYCN regardless of tumor histology (may meet criteria for may meet criteria for high risk classification but are not eligible for this trial)
  • Can not have bone marrow failure syndromes
  • Can not be pregnancy or breast feeding
  • Sexually active patients of reproductive potential must agree to use an effective contraceptive method

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics