Completed

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

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What is being tested

hu14.18-Interleukin-2 fusion protein

Biological
Who is being recruted

Neoplasms+7

+ Neoplasms by Histologic Type

+ Neoplasms, Germ Cell and Embryonal

Until 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2005
See protocol details

Summary

Principal SponsorChildren's Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2005

Actual date on which the first participant was enrolled.

OBJECTIVES: * Determine the response rate in children with recurrent or refractory neuroblastoma treated with hu14.18-interleukin-2 (hu14.18-IL2) fusion protein. * Determine the adverse events of this drug in these patients. * Determine the immunologic activation in patients treated with this drug. * Determine the induction of anti-hu14.18-IL2 antibody in patients treated with this drug. * Correlate antitumor response with measurements of toxicity, immune activation, and anti-hu14.18-IL2 antibody activity in patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to measurable/evaluable disease (measurable by standard radiographic criteria vs evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or bone marrow histology vs disease identified and quantified by bone marrow immunohistochemistry). For standard radiographic criteria this study will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. Complete Response (CR) - Disappearance of all target lesions. No evidence of tumor at any site (chest, abdomen, liver, bone, bone marrow, nodes, etc). Very Good Partial Response (VGPR) - Greater than 90% decrease of the disease measurement for CT/MRI target lesions, taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry; all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Partial Response (PR) - At least a 30% decrease in the disease measurement for CT/MRI target lesions, taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry. Progressive Disease (PD) - Any one of the following: a) At least a 20% increase in the disease measurement for CT/MRI target lesions, taking as reference the smallest disease measurement recorded since the start of treatment. b) Appearance of one or more new lesions or new sites of tumor. c) PD as defined above for either bone marrow or MIBG lesions. Stable disease (SD) - The patient will be classified as stable disease for overall response if there is stable disease by either CT/MRI lesion, bone marrow, or MIBG criteria. No new lesions; no new sites of disease. Patients will be enrolled in 3 strata, and evaluated for antitumor response following 2 monthly courses (treatment on Days 1-3, followed by 25 days of observation,). Patients with progressive disease will be taken off protocol therapy. Patients with stabilization or regression of disease will be eligible to receive 2 more monthly courses of treatment. Additional treatment following course 4 will be allowed for patients showing a continued clinical response, up to a maximum of 10 courses of treatment. Patients are followed for survival. PROJECTED ACCRUAL: A total of 40-60 patients (20 for strata 1 and 2 and 0-20 for stratum 3) will be accrued for this study within 2 years.

Official TitleA Phase II Study Of hu14.18-IL2 In Children With Recurrent Or Refractory Neuroblastoma 
NCT00082758
Principal SponsorChildren's Oncology Group
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroblastomaNeuroectodermal TumorsNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, Neuroepithelial

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology. hu14.18-Interleukin-2 fusion protein : Given IV

Group II

Experimental
Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells). hu14.18-Interleukin-2 fusion protein : Given IV

Group III

Experimental
Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. hu14.18-Interleukin-2 fusion protein : Given IV

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 81 locations

Suspended

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, United StatesSee the location
Suspended

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, United States
Suspended

Childrens Hospital Los Angeles

Los Angeles, United States
Suspended

Children's Hospital Central California

Madera, United States
Completed81 Study Centers