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:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT00072358
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of neuroblastoma by histopathology OR bone marrow metastases and high urine catecholamine levels
* Disease must meet risk-related treatment guidelines and any of the following International Neuroblastoma Staging System stages:
* Stage 4 with (any age) OR without (\> 18 months of age of age) MYCN amplification
* MYCN-amplified other than stage 1
* No evidence of disease (i.e., in complete response/remission or very good partial response/remission) OR disease resistant to standard therapy (i.e., incomplete response in bone marrow)
* No progressive disease or MIBG-avid soft tissue tumor
PATIENT CHARACTERISTICS:
* No existing renal, cardiac, hepatic, neurologic, pulmonary, or gastrointestinal toxicity ≥ grade 3
* No human anti-mouse antibody (HAMA) titer greater than 1,000 Elisa units/mL
* No history of allergy to mouse proteins
* No active life-threatening infection
* Not pregnant
* Negative pregnancy test
PRIOR CONCURRENT THERAPY:
* Not specified
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00072358
Study Brief:
Protocol Section:
NCT00072358