Clinical trial · Interventional
hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
A Phase II Study Of hu14.18-IL2 In Children With Recurrent Or Refractory Neuroblastoma
NCT00082758CI-TRIAL-00016857completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hu14.18-Interleukin-2 fusion protein | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Disease Measurable by Standard Criteria(hu14.18-interleukin-2)
- description
- 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
- interventionNames
- Biological: hu14.18-Interleukin-2 fusion protein
- type
- EXPERIMENTAL
- label
- Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)
- description
- 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
- interventionNames
- Biological: hu14.18-Interleukin-2 fusion protein
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTDelgado DC, Hank JA, Kolesar J, Lorentzen D, Gan J, Seo S, Kim K, Shusterman S, Gillies SD, Reisfeld RA, Yang R, Gadbaw B, DeSantes KB, London WB, Seeger RC, Maris JM, Sondel PM. Genotypes of NK cell KIR receptors, their ligands, and Fcgamma receptors in the response of neuroblastoma patients to Hu14.18-IL2 immunotherapy. Cancer Res. 2010 Dec 1;70(23):9554-61. doi: 10.1158/0008-5472.CAN-10-2211. Epub 2010 Oct 8. PMID 20935224
- RESULTShusterman S, London WB, Gillies SD, Hank JA, Voss SD, Seeger RC, Reynolds CP, Kimball J, Albertini MR, Wagner B, Gan J, Eickhoff J, DeSantes KB, Cohn SL, Hecht T, Gadbaw B, Reisfeld RA, Maris JM, Sondel PM. Antitumor activity of hu14.18-IL2 in patients with relapsed/refractory neuroblastoma: a Children's Oncology Group (COG) phase II study. J Clin Oncol. 2010 Nov 20;28(33):4969-75. doi: 10.1200/JCO.2009.27.8861. Epub 2010 Oct 4. PMID 20921469