Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT00389766
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT00389766
Study Brief:
Protocol Section:
NCT00389766