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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00083135
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of neuroblastoma
* Confirmed by at least 1 of the following methods:
* Histology
* Clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
* High-risk disease
* Poor response to induction therapy OR relapse defined by any of the following:
* No response, stable disease, or mixed response after a minimum of 3 prior courses of chemotherapy
* More than 100 tumor cells per 10\^5 nucleated cells on bone marrow immunocytology after at least 3 prior courses of chemotherapy
* Progressive disease at any time during or after therapy
* Patients with massive bone marrow invasion (more than 50% replacement of bone marrow by tumor cells) are allowed
* Must have positive iodine I 131 metaiodobenzylguanidine (\^131I-MIBG) within the past 6 weeks or subsequent to any other prior antitumor therapy delivered within the past 6 weeks
* Must meet the following criteria for minimum number of autologous stem cells:
* Unpurged peripheral blood stem cells (PBSC)
* Minimum of 1,500,000/mm\^3 CD34-positive cells/kg
* Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology
* PBSC purged with immunomagnetic beads
* Minimum of 1,000,000/mm\^3 viable CD34-positive cells/kg
* Collected products must have \< 1 tumor cell/100,000 normal cells by immunocytology
* CD34-positive selected PBSC products are not allowed
* Patients who had PBSC collected previously with no immunocytological testing available may use those products provided bone marrow is tumor free by bilateral bone marrow aspirate AND biopsy for morphology is performed within 4 weeks before PBSC collection
* Patients with no tumor involvement in bone marrow at diagnosis and PBSC collection before any disease progression do not require documentation of negative bone marrow morphology
PATIENT CHARACTERISTICS:
Age
* 1 to 30
Performance status
* ECOG 0-2
Life expectancy
* Less than 1 year
Hematopoietic
* Absolute neutrophil count ≥ 500/mm\^3
* Platelet count ≥ 50,000/mm\^3 (without transfusion)
* Hemoglobin ≥ 8 g/dL (transfusion allowed)
Hepatic
* AST and ALT ≤ 5 times normal
* Bilirubin \< 2 times normal
Renal
* Creatinine ≤ 1.5 mg/dL
* Glomerular filtration rate OR 12-hour creatinine clearance ≥ 60 mL/min/1.73m\^2
Cardiovascular
* Ejection fraction ≥ 55% by echocardiogram or MUGA OR
* Fractional shortening ≥ 30% OR above lower limit of normal by echocardiogram
Pulmonary
* Normal lung function
* No dyspnea at rest
* No exercise intolerance
* No oxygen requirement
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to cooperate physically and psychologically with radiation isolation
* No disease of any major organ system that would preclude study participation
* No active infection requiring antivirals, antibiotics, or antifungals
* No weight that would require exceeding a maximum total allowable dose of \^131I-MIBG
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 2 weeks since prior biologic or other non-myelosuppressive therapy
Chemotherapy
* See Disease Characteristics
* At least 2 weeks since prior chemotherapy
* More than 3 months since prior myeloablative therapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 6 months since prior craniospinal, total abdominal, or whole lung radiotherapy
* At least 2 weeks since prior radiotherapy to any site
* No prior total body irradiation
* No prior radiotherapy to \> 25% of bone marrow
* No prior \^131I-MIBG
Surgery
* Not specified
Other
* Recovered from all prior therapy
* Concurrent antifungal therapy allowed provided culture and biopsy are negative in suspected radiographic lesions
* Prior re-induction therapy for recurrent tumor allowed
* No concurrent antiretroviral therapy for HIV-positive patients
* No concurrent hemodialysis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
30 Years
Study:
NCT00083135
Study Brief:
Protocol Section:
NCT00083135