Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors

RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors.

OBJECTIVES:

* Determine the maximum tolerated dose of hu14.18-interleukin-2 fusion protein in children with refractory or recurrent neuroblastoma or other GD2-positive tumors.
* Determine the toxicity and pharmacokinetics of the fusion protein in these patients.
* Determine the effect of the fusion protein on systemic immune modulation in these patients.
* Quantitate the antifusion protein antibodies in patients treated with fusion protein.
* Evaluate antitumor responses resulting from this fusion protein regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive hu14.18-interleukin-2 (hu14.18-IL2) fusion protein IV over 4 hours once daily on days 1-3. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of hu14.18-IL2 fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months for 1 year, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1 year.

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