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

Not Recruiting

Trial ID: NCT00082758


RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing. PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma.

Official Title

A Phase II Study Of hu14.18-IL2 In Children With Recurrent Or Refractory Neuroblastoma

Stanford Investigator(s)



   - 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

   - No clinical or radiological evidence of central nervous system (CNS) disease



   - 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


   - 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


   - Alanine transaminase (ALT) < 2.5 times upper limit of normal (ULN)

   - Bilirubin ≤ 1.5 times ULN

   - Hepatitis B surface antigen negative


   - 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


   - 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


   - 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)


   - 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


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


   - 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


   - 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


   - More than 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy)

   - No prior organ allografts


   - No concurrent immunosuppressive drugs

   - No other concurrent myelosuppressive antineoplastic drugs


biological: hu14.18-Interleukin-2 fusion protein

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
LPCH New Patient Coordinator

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