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 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT00054405
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of neuroblastoma
* Histologically confirmed disease AND/OR disease defined by tumor cells in the bone marrow and elevated urinary catecholamine metabolites
* Persistent and/or refractory disease, with at least 1 of the following:
* Biopsy-proven residual disease at least 12 weeks after myeloablative therapy
* Progressive disease after nonmyeloablative or myeloablative therapy
* Recurrent disease, evidenced by any of the following:
* Biopsy-proven recurrent soft tissue disease
* Metaiodobenzylguanidine (MIBG)-positive lesions visible on any other imaging modality or repeat MIBG obtained 2-4 weeks or more apart
* Histologically confirmed bone marrow disease
* Progressive or stable disease after at least 1 prior standard salvage regime
* No clinically significant pleural effusion
* ECOG 0-1
* Life expectancy \>= 12 weeks
* Hepatitis A antibody negative
* Hepatitis B surface antigen negative
* Positive hepatitis B titer allowed if patient has been immunized and has no history of disease
* Hepatitis C virus negative
* No history of congenital or acquired coagulation disorder
* Cardiac function normal by ECG
* No dyspnea at rest
* No exercise intolerance
* Oxygen saturation at least 94% by pulse oximetry
* DLCO greater than 60% of predicted
* FEV1 greater than 70% of predicted
* Negative pregnancy test
* Skull-based bony lesions without space-occupying intracranial extension are allowed
* No prior or concurrent intracranial metastatic disease to the brain parenchyma
* Not pregnant or nursing
* Fertile patients must use effective barrier contraception during and for at least 2 months after study
* No prior hematologic malignancy (including leukemia or lymphoma)
* No history of malignant hyperthermia
* No prior or concurrent autoimmune disease
* No positive direct Coombs testing
* No history of ongoing or intermittent bowel obstruction
* No active infection or other significant systemic illness
* More than 2 weeks since prior fenretinide
* More than 2 weeks since prior 13-cis-retinoic acid
* More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
* More than 2 weeks since prior interferons or interleukins
* More than 2 weeks since prior cytokine-fusion proteins
* More than 2 weeks since prior IV immunoglobulin (IVIG)
* No prior interleukin-12
* No concurrent cytokines
* No concurrent fenretinide
* No concurrent 13-cis-retinoic acid
* No other concurrent immunomodulators, including:
* G-CSF and GM-CSF
* Interferons
* Other interleukins
* IVIG
* More than 4 weeks since prior chemotherapy
* No other unstable medical condition or critical illness that would preclude study participation
* More than 12 weeks since prior myeloablative chemotherapy followed by autologous stem cell transplantation:
No prior myeloablative chemotherapy followed by allogeneic bone marrow transplantation
* More than 2 weeks since prior growth hormones
* More than 4 weeks since prior systemic corticosteroids
* More than 2 weeks since prior non-corticosteroid hormonal therapy (including oral birth control pills)
* No concurrent hormonal therapy (including oral birth control pills)
* No concurrent growth hormones
* No concurrent systemic corticosteroids, except for use in life-threatening complications
* More than 4 weeks since prior radiotherapy
* No prior solid organ transplantation
* More than 4 weeks since prior investigational agents
* No other concurrent investigational agents
* No prior enrollment on COG-A3973, unless disease has progressed
* No history of hemolytic anemia
* Absolute neutrophil count at least 1,500/mm\^3 \[Note: Independent of growth factor or transfusion support\]
* Platelet count at least 75,000/mm\^3 \[Note: Independent of growth factor or transfusion support\]
* AST and ALT less than 2.5 times upper limit of normal
* Bilirubin less than 2.0 mg/dL
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR creatinine normal
* HIV negative
* Ejection fraction at least 50% by echocardiogram or MUGA OR Fractional shortening at least 30% by echocardiogram
* No congestive heart failure
* No uncontrolled cardiac arrhythmia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
21 Years
Study:
NCT00054405
Study Brief:
Protocol Section:
NCT00054405