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

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 scanning
  • Immunocytochemistry
• No symptomatic pleural effusions or ascites requiring constant or intermittent drainage
• No clinical or radiological evidence of 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

• 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 MUGA
• No symptomatic congestive heart failure
• No uncontrolled cardiac rhythm disturbance

Pulmonary

• Pulse oximetry > 94% on room air
• FVC > 80%
• 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