Iobenguane I-131 in Treating Patients with Recurrent or Refractory Neuroblastoma or Non-neuroblastic Iobenguane Avid Tumors

Inclusion Criteria

• Patients must have a diagnosis of neuroblastoma verified at diagnosis, or at the time of relapse by histology and/or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; patients with non-neuroblastic MIBG avid tumors are also eligible including but not limited to paraganglioma and pheochromocytoma
• Patients must meet one of the following criteria: * The presence of refractory or progressive disease (PD) prior to or following completion of standard therapy for MIBG avid tumors * For patients with neuroblastoma, the presence of mixed response (MR), or no response (NR) following the completion of A3973 or equivalent induction therapy, or the presence of a partial response (PR) with high Curie score (> 2) following induction therapy * Patients with de novo high risk neuroblastoma who have completed standard induction therapy and do not achieve a complete response (CR), very good partial response (VGPR), or PR with low Curie score post induction are eligible; for patients with neuroblastoma the revised International Neuroblastoma Response Criteria (INRC) shall be used to assess pre-treatment disease status
• Patients must have evidence of MIBG avid disease as determined by diagnostic MIBG scan obtained within 4 weeks of MIBG infusion; at least one MIBG avid target lesion that can be evaluated for response must be present at study entry; computed tomography (CT)/magnetic resonance imaging (MRI) evaluation of all sites of disease must be completed within 4 weeks of MIBG infusion
• Patients who receive greater than 12 mCi/kg are required to have stem cell rescue products harvested prior to study treatment; a minimum frozen autologous peripheral blood stem cell (PBSC) collection of 4 x 10^6 cluster of differentiation (CD)34+ cells/kg as 2 aliquots is the suggested dose; for subjects receiving < 12 mCi/ kg, a backup of 2.0 X 10^6 viable CD34+ cells/kg purged or unpurged PBSC is strongly recommended but not required
• Patients must have a Lansky Play Scale of 60% (< 16 years [yrs] old), Karnofsky score 60% (> 16 yrs old), or Eastern Cooperative Oncology Group (ECOG) score of < or equal to 2 and a life expectancy of 2 months
• Patients may enter this study with or without salvage therapy for recurrent tumor; patients must have fully recovered from the toxic effects of any prior therapy; * Myelosuppressive chemotherapy and/or biologics: must not have received within 3 weeks of entry onto this study; (6 weeks in the case of mitomycin C or nitrosourea-containing therapy) * Radiation therapy (XRT): 6 weeks must have elapsed since completing radiation therapy to any site (6 months in the case of craniospinal, whole lung); patients are excluded if they have received local radiation which includes any of the following: ** 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed) ** 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver ** Prior MIBG therapy: should be at least 42 days from previous 131I-MIBG therapy and have recovered completely from all clinically significant treatment associated toxicities; patients must not exceed a lifetime cumulative injected activity of 54 mCi/kg for patients with neuroblastoma and 36 mCi/kg for patients with other MIBG avid diseases; patients must have demonstrated a response to prior MIBG therapy (either clinical, pathological and/or radiographic improvement)
• Hemoglobin 10 gl/dl (transfusion allowed)
• Absolute neutrophil count (ANC) 550/cu mm (off myeloid growth factors)
• Platelets > 50,000/cu mm (transfusion allowed - however patients must not require more than two platelet transfusions per week)
• Serum creatinine < 2 x upper limit of normal (ULN) for age 1 to < 2 yrs males: 0.6 females: 0.6 2 to < 6 yrs males: 0.8 females: 0.8 6 to < 10 yrs males: 1 females: 1 10 to < 13 yrs males: 1.2 females: 1.2 13 to < 16 yrs males: 1.5 females: 1.4 17 to 20 yrs males: 1.7 females: 1.4 Over 21 yrs males: 2 x ULN females: 2 x ULN
• Total bilirubin < 1.5 x ULN for age
• Serum glutamate pyruvate transaminase (SGPT) alanine aminotransferase (ALT) and serum glutamic-oxaloacetic transaminase (SGOT) aspartate aminotransferases (AST) < 10 x ULN for age
• For children with neuroblastoma (NBL): normal ejection fraction (> 55%) documented by echocardiogram or radionuclide multi-gated acquisition (MUGA) evaluation OR normal fractional shortening (> 27%) documented by echocardiogram; for subjects with paraganglioma/ pheochromocytoma: no clinically significant cardiac dysfunction
• Patients must have clinically normal lung function as manifested by no dyspnea at rest and no oxygen requirement
• Females of childbearing potential must have a negative pregnancy test within 1 week prior to treatment with 131I-MIBG
• Patients of childbearing potential must agree to use an effective birth control method
• Female patients who are lactating must agree to stop breast feeding

Exclusion Criteria

• Pregnancy or breast feeding
• Have undergone a prior allogeneic bone marrow transplant (BMT)
• Patients with disease of any major organ system that would compromise their ability to withstand therapy; any significant organ impairment should be discussed with the study chair prior to patient entry
• Patients who are on hemodialysis
• Hepatitis B surface antigen (+) or hepatitis C positive in preceding six months
• Patients with an active infection requiring intravenous antivirals, antibiotics or antifungals; patients on prolonged antifungal therapy are still eligible if they are culture negative and biopsy negative in suspected residual radiographic lesions have stabilized or regressed and they meet other organ function criteria
• Prior total body irradiation, prior total abdominal or whole liver radiation
• Any medical or psychological condition or situation deemed by the principal investigator (PI) to put the patient at increased risk of complications or noncompliance
• Patients with curative treatment options
• Patients for whom busulfan/melphalan consolidation therapy following treatment with 131I-MIBG is planned
• Patients for who CEM (carboplatin, etoposide, melphalan) therapy is administered within 30 days prior to 131I-MIBG therapy or for whom this therapy is planned within 30 days following administration of 131I-MIBG