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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT00082758
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed neuroblastoma
* Relapsed or refractory to conventional therapy
* Measurable or evaluable disease documented by 1 of the following criteria:
* Clinical
* Radiographic
* Histologic
* MIBG (meta-iodobenzylguanidine) scanning
* Immunocytochemistry
* No symptomatic pleural effusions or ascites requiring constant or intermittent drainage
* No clinical or radiological evidence of central nervous system (CNS) disease
PATIENT CHARACTERISTICS:
Age
* 21 and under
Performance status
* Karnofsky 50-100% (\> 16 years of age)
* Lansky 50-100% (≤ 16 years of age)
Life expectancy
* At least 8 weeks
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count ≥ 75,000/mm\^3\*
* Must not be refractory to platelet transfusions
* Hemoglobin ≥ 9.0 g/dL\* NOTE: \*Transfusion allowed if patient is known to have a history of bone marrow involvement with tumor
Hepatic
* Alanine transaminase (ALT) \< 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Hepatitis B surface antigen negative
Renal
* Creatinine adjusted according to age as follows:
* No greater than 0.4 mg/dL (≤ 5 months)
* No greater than 0.5 mg/dL (6 months -11 months)
* No greater than 0.6 mg/dL (1 year-23 months)
* No greater than 0.8 mg/dL (2 years-5 years)
* No greater than 1.0 mg/dL (6 years-9 years)
* No greater than 1.2 mg/dL (10 years-12 years)
* No greater than 1.4 mg/dL (13 years and over \[female\])
* No greater than 1.5 mg/dL (13 years to 15 years \[male\])
* No greater than 1.7 mg/dL (16 years and over \[male\]) OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular
* Shortening fraction ≥ 27% by echocardiogram OR
* Ejection fraction ≥ 50% by Multi Gated Acquisition Scan (MUGA)
* No symptomatic congestive heart failure
* No uncontrolled cardiac rhythm disturbance
Pulmonary
* Pulse oximetry \> 94% on room air
* Forced vital capacity (FVC) \> 80%
* Forced expiratory volume (FEV\_1) \> 80%
* No abnormal respiratory function
* No dyspnea at rest
* No exercise intolerance
* No prior history of ventilator support related to lung injury (e.g., pneumonia, hemorrhagic pneumonitis, or capillary leakage)
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active uncontrolled infection
* No active uncontrolled peptic ulcer
* No objective peripheral neuropathy ≥ grade 2
* No significant psychiatric disabilities
* No seizure disorders requiring antiseizure medications
* No other concurrent significant illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Recovered from prior immunotherapy
* Prior in vivo monoclonal antibodies for biologic therapy or tumor imaging allowed provided there is documented absence of detectable antibody to hu14.18 by serology
* More than 28 days since prior autologous stem cell transplantation
* Prior autologous marrow or stem cell infusion using monoclonal antibody-purged specimens allowed
* More than 1 week since prior growth factors
* At least 7 days since prior nonmyelosuppressive biologic agents
* No prior allogeneic bone marrow or stem cell transplantation
* No concurrent immunomodulating agents
* No concurrent growth factors
Chemotherapy
* More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
* No concurrent anticancer chemotherapy
Endocrine therapy
* No concurrent corticosteroids except 100 mg or less of hydrocortisone (or equivalent) as premedication for blood transfusion or treatment for transfusion reaction
* No other use of systemic steroids
Radiotherapy
* Recovered from prior radiotherapy
* At least 2 weeks since prior local palliative radiotherapy (small port)
* At least 6 months since prior craniospinal radiotherapy
* At least 6 months since prior total body irradiation
* At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
* At least 6 weeks since other prior substantial bone marrow radiotherapy
* Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable or evaluable lesion is not irradiated
Surgery
* More than 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy)
* No prior organ allografts
Other
* No concurrent immunosuppressive drugs
* No other concurrent myelosuppressive antineoplastic drugs
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00082758
Study Brief:
Protocol Section:
NCT00082758