Status:
WITHDRAWN
High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma
Lead Sponsor:
Children's Cancer and Leukaemia Group
Conditions:
Neuroblastoma
Eligibility:
All Genders
1-17 years
Phase:
PHASE2
Brief Summary
RATIONALE: Radioisotope therapy, such as iodine I 131 metaiodobenzylguanidine (MIBG), releases radiation that kills tumor cells. Drugs used in chemotherapy, such as topotecan, work in different ways t...
Detailed Description
OBJECTIVES: * Determine response (partial and complete response at metastatic sites) in children with relapsed stage 4 neuroblastoma or primary resistant high-risk neuroblastoma treated with high-dos...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of neuroblastoma meeting the 1 of the following criteria:
- Primary resistant high-risk disease meeting the following criteria:
- International neuroblastoma staging system (INSS) stage 4, or stage 2 or 3 with myelocytomatosis viral-related oncogene (MycN) amplification
- Failed to achieve satisfactory remission with induction chemotherapy, defined as one of the following:
- Less than 50% reduction or \> 3 positive sites on iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) scintigraphy
- Persistent cytomorphological positive disease in bone marrow aspirates or trephine biopsies
- Progressive disease necessitating a change of treatment
- Relapsed stage 4 disease meeting the following criteria:
- High-risk neuroblastoma (INSS stage 4, or stage 2 or 3 with MycN amplification)
- Relapsed after intensive treatment including high-dose chemotherapy and hematopoietic progenitor cell support
- Patients may be entered at the time of relapse, or at any point subsequently after other treatments
- \^131I-MIBG-positive disease on diagnostic scintigraphy
- Peripheral blood stem cell harvest ≥ 300,000/mm³ CD 34+ cells
- Enrolled in or has been treated on protocol SIOP-NB-2009 or a similar protocol
- PATIENT CHARACTERISTICS:
- Glomerular filtration rate ≥ 50 mL/min
- Considered fit enough to undergo proposed study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00389766
Start Date
July 1 2008
Last Update
July 10 2013
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