Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed… (NCT01175356) | Clinical Trial Compass
CompletedPhase 1
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
United States99 participantsStarted 2011-12-21
Plain-language 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.
Who can participate
Age range1 Year – 30 Years
SexALL
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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 …
What they're measuring
1
Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131
Timeframe: Up to 6 weeks after course 5 of induction
2
Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy