Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Children's Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: hu14.18-Interleukin-2 fusion protein

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

N/A - 21 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
LPCH New Patient Coordinator
6507251072
Not Recruiting