hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma

Inclusion 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