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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT00003750
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed neuroblastoma or melanoma at original diagnosis
* Refractory to chemotherapy or recurrence after prior multiagent chemotherapy
* Measurable or evaluable (detectable by bone scan) metastatic disease OR
* No evidence of disease if complete response to prior surgical resection, radiotherapy, and/or chemotherapy OR
* Histologically confirmed tumor expressing GD2 antigen at original diagnosis or relapse
* Refractory to standard treatment
* Measurable or evaluable disease by clinical assessments or laboratory markers OR
* No evidence of disease after prior surgical resection of metastatic, recurrent disease
* Histologically confirmed recurrent osteogenic sarcoma after prior chemotherapy allowed
* Soft tissue sarcoma allowed
* No primary CNS tumors
* Prior CNS metastases allowed, provided:
* Disease previously treated
* Disease clinically stable for 4 weeks before study
* At least 4 weeks since prior steroids for CNS metastases
* No clinically detectable pleural effusions or ascites
PATIENT CHARACTERISTICS:
Age:
* 21 and under
Performance status:
* Karnofsky 60-100% for children over age 10
* Lansky 60-100% for children age 10 and under
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count at least 75,000/mm\^3 (transfusion allowed)
* Hemoglobin at least 9.0 g/dL (transfusion allowed)
Hepatic:
* Bilirubin less than 1.5 mg/dL
* ALT or AST no greater than 2.5 times normal
* Hepatitis B surface antigen negative
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min
Cardiovascular:
* Shortening fraction at least 27% by echocardiogram OR
* Ejection fraction more than 50% by MUGA scan
* No congestive heart failure
* No uncontrolled cardiac rhythm disturbance
Pulmonary:
* FEV\_1 and FVC more than 60% of predicted OR
* No dyspnea at rest
* No exercise intolerance
* Oxygen saturation more than 94% by pulse oximetry on room air
Neurologic:
* No seizure disorders requiring antiseizure medications
* No significant neurologic deficit or grade 2 or greater objective peripheral neuropathy
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No significant concurrent illnesses unrelated to cancer or its treatment
* No significant psychiatric disabilities
* No uncontrolled active infections
* No uncontrolled active peptic ulcer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 1 week since prior growth factors
* At least 1 week since prior immunomodulatory therapy
* Prior monoclonal antibodies allowed if no detectable antibody to hu14.18
* Prior autologous bone marrow transplantation (BMT) or stem cell transplantation (SCT) allowed
* Prior autologous BMT or SCT with monoclonal antibody-purged specimens allowed
* No concurrent growth factors
* No concurrent interferon
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or melphalan)
* No concurrent palliative chemotherapy
Endocrine therapy:
* See Disease Characteristics
* At least 2 weeks since prior glucocorticoids, except for life-threatening symptoms
* No concurrent corticosteroids
* No concurrent glucocorticoids, except for life-threatening symptoms
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* No concurrent palliative radiotherapy
Surgery:
* See Disease Characteristics
* At least 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy)
* No prior organ allografts
* No concurrent palliative surgery
Other:
* Recovered from prior therapy
* At least 1 week since prior tretinoin
* At least 3 weeks since prior immunosuppressive therapy
* No other concurrent immunosuppressive drugs
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT00003750
Study Brief:
Protocol Section:
NCT00003750