©2022 Stanford Medicine
hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Not Recruiting
Trial ID: NCT00082758
Purpose
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)
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
Intervention(s):
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
6507251072