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

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