n2007-01: ultratrace™ iobenguane i 131 in patients with relapsed/refractory high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: radioactive drugs, such as iodine i 131 metaiodobenzylguanidine (mibg), may carry radiation directly to tumor cells and not harm normal cells. a bone marrow or peripheral stem cell transplant using stem cells from the patient may be able to replace blood-forming cells that were destroyed by i 131 mibg. purpose: this phase ii trial is studying the side effects and best dose of iodine i 131 mibg followed by a stem cell transplant in treating young patients with relapsed or refractory high-risk neuroblastoma.

objectives: primary * to establish the maximum tolerated dose of iodine i 131 metaiodobenzylguanidine (\^131i-mibg) in patients with relapsed/refractory high-risk neuroblastoma. secondary * to describe toxicity following treatment with \^131i-mibg in patients with relapsed/refractory high-risk neuroblastoma. * to estimate radiation absorbed doses to measurable lesions and to a standard set of normal organs following a 0.1 mci/kg \[3.7 mbq/kg\] (minimum dose of 1.0 mci \[37 mbq\] but not to exceed 5.0 mci \[185 mbq\]) intravenous administration of \^131i-mibg in patients with relapsed/refractory high-risk neuroblastoma. * to describe, within the confines of a phase iia trial, objective tumor response following treatment with \^131i-mibg in patients with relapsed/refractory high-risk neuroblastoma. * to explore dose-response following treatment with \^131i-mibg in patients with relapsed/refractory high-risk neuroblastoma. * to explore quality of life assessment following treatment with \^131i-mibg in patients with relapsed/refractory high-risk neuroblastoma. outline: * dosimetry: patients receive a dosimetric dose of iodine i 131 metaiodobenzylguanidine (\^131i-mibg) iv over 1-3 minutes. patients then undergo 2 or 3 mibg scans within 5 days of the dosimetry dose to assess biodistribution and tumor uptake. patients with normal tumor uptake and biodistribution proceed to treatment. * treatment: within 1-4 weeks of the dosimetric dose, patients with normal tumor uptake and biodistribution receive a therapeutic dose of \^131i-mibg iv over 1 hour on day 0 and undergo mibg scan on day 7. patients then proceed to autologous stem cell infusion. * autologous stem cell infusion: patients receive an infusion of autologous stem cells from peripheral blood or bone marrow on day 14. patients with an anc of \ 2,000/µl. patients complete a quality of life questionnaire at baseline and then at day 60. after completion of study treatment, patients are followed at day 60 and periodically thereafter.

Eligibility criteria:
inclusion criteria: * patients must be at least one year and no more than 30 years of age when registered on this study. * patients must have high risk neuroblastoma and either have tumor left after treatment started at diagnosis or have had the tumor grow back (relapsed) after getting some treatment * patients must an mibg scan done and it must be positive for neuroblastoma. * patients must have a pbsc or bone marrow stem cell product available that meets study criteria. if they don't already have stem cells frozen away then they must be able to have a stem cell pheresis done to collect the necessary amount of stem cells for study entry and these stem cells must meet study criteria. * patients must have adequate heart, lung, liver, kidney and bone marrow function. exclusion criteria: * they have had a stem cell transplant using another person as the stem cell donor. (you can still be in the study if a previous transplant used your own stem cells) * they have other medical problems that could get much worse if they had this treatment. * they are on dialysis for badly working kidneys or have other kidney problems. * they are pregnant or breast feeding. * they have tumor in the brain or spinal cord that is seen on a ct or mri scan one month before starting treatment * they had total body radiation or radiation to the entire belly. * they have a known allergy to mibg, iodine or sski. * they can't cooperate with the special precautions that are needed during ultratracetm mibg treatment or with other safety monitoring requirements of the study..

Keywords: recurrent neuroblastoma