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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT00033293
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed neuroblastoma (NBL) or ganglioneuroblastoma with tumor-associated opsoclonus-myoclonus-ataxia syndrome (OMA)
* Patients with NBL diagnosed within 6 months of OMA diagnosis AND patients with OMA diagnosed within 6 months of NBL diagnosis are eligible
* Must enroll on study within 4 weeks of diagnosis
* Presence of opsoclonus, myoclonus, and/or ataxia associated with neuroblastoma considered eligible
* Currently enrolled on COG neuroblastoma protocols: COG-ANBL00B1 or its successor
* Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
* ≤ 0.4 mg/dL (for patients 1 to 5 months of age)
* ≤ 0.5 mg/dL (for patients 6 to 11 months of age)
* ≤ 0.6 mg/dL (for patients 1 year of age)
* ≤ 0.8 mg/dL (for patients 2 to 5 years of age)
* ≤ 1.0 mg/dL (for patients 6 to 9 years of age)
* ≤ 1.2 mg/dL (for patients 10 to 12 years of age)
* ≤ 1.4 mg/dL (for female patients ≥ 13 years of age)
* ≤ 1.5 mg/dL (for male patients 13 to 15 years of age)
* ≤ 1.6 mg/dL (for male patients ≥ 16 years of age)
* No prior IV gamma globulin therapy
* No prior chemotherapy
* Concurrent chemotherapy allowed
* No prior prednisone or corticotropin
* Patients who have received ≤ 14 days of steroids are eligible
* Concurrent surgery allowed
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
8 Years
Study:
NCT00033293
Study Brief:
Protocol Section:
NCT00033293