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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT00253435
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of relapsed or refractory neuroblastoma
* Histologically confirmed and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites
* High-risk neuroblastoma must meet one of the following:
* Progressive disease prior to or after completion of induction therapy
* Mixed response or no response after completion of 4 courses of induction therapy
* Partial response after 4 courses of induction therapy allowed provided no prior participation in COG-A3973 or other phase III COG trials
* Measurable disease, defined as at least one metaiodobenzylguanidine (MIBG)-avid target lesion determined by diagnostic MIBG scan within 6 weeks of study entry (tumor sites that have received local irradiation within 3 months of study entry are not considered target lesions)
PATIENT CHARACTERISTICS:
Performance status
* Lansky 60-100% OR
* Karnofsky 60-100%
Life expectancy
* At least 2 months
Hematopoietic
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 750/mm\^3
* Platelet count ≥ 50,000/mm\^3 (if no marrow involvement by morphologic exam/no transfusion allowed) (\> 20,000/mm\^3 if metastatic tumor involvement of marrow by morphologic exam/transfusion allowed)
Hepatic
* Bilirubin \< 1.3 mg/dL
* SGOT and SGPT \< 5 times normal
* Hepatitis B surface antigen negative
* Hepatitis C negative
Renal
* Glomerular filtration rate or creatinine clearance ≥ 60 ml/min
* Creatinine ≤ 1.5 times normal for age as follows:
* 0.8 mg/dL (for patients ≤ 5 years of age)
* 1.0 mg/dL (for patients 6 to 10 years of age)
* 1.2 mg/dL (for patients 11 to 15 years of age)
* 1.5 mg/dL (for patients \> 15 years of age)
Cardiovascular
* Ejection fraction ≥ 55% by echocardiogram or radionuclide MUGA OR
* Fractional shortening ≥ 27% by echocardiogram
Pulmonary
* Normal lung function defined as no dyspnea at rest and no oxygen requirement OR measured oxygen saturation \> 93% on room air
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No disease of any major organ system that would preclude study compliance
* No concurrent hemodialysis
* No active infection requiring IV antivirals, antibiotics, or antifungals (patients on antifungal therapy are eligible provided they are culture- and biopsy-negative in suspected residual radiographic lesions)
* Patient weight within limits to receive ≤ maximum total allowable dose of \^131I-MIBG
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior myeloablative transplantation
* Prior submyeloablative transplantation allowed at discretion of principal investigator
* More than 3 weeks since prior biologic therapy
Chemotherapy
* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for mitomycin C or nitrosoureas)
* No prior melphalan therapy with a total dose of \> 100 mg/m\^2
Radiotherapy
* See Disease Characteristics
* At least 6 weeks since prior radiotherapy (6 months for craniospinal or whole lung radiotherapy)
* No prior total body irradiation
* No prior iodine I 131 MIBG (\^131I-MIBG)
* No prior total abdominal or whole liver radiotherapy
* No prior local radiotherapy, including any of the following:
* 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed)
* 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver
Other
* Recovered from all prior therapy
* No medications with a potential interference of \^131I-MIBG uptake 1 week before and 2 weeks after completion of \^131I-MIBG
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
29 Years
Study:
NCT00253435
Study Brief:
Protocol Section:
NCT00253435