Clinical trial · Interventional
Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
A Phase I/IB Intergroup Trial of the HU14.18-IL2 Fusion Protein in Children With Refractory Neuroblastoma and Other GD2 Positive Tumors
NCT00003750CI-TRIAL-00015343completedPhase 1ClinicalTrials.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 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in treating children who have refractory or recurrent neuroblastoma or other tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hu14.18-IL2 fusion protein | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DG2 positive relapsed or refractory solid tumors
- description
- The initial hu14.18-IL2 fusion protein (FP) dose will be 2 mg/m2 given intravenously over 4 hours, daily for 3 days. Five separate dose levels are scheduled: 2 mg/m²/dose (IV over 4 hours) x 3 days, 4 mg/m²/dose (IV over 4 hours) x 3 days, 6 mg/m²/dose (IV over 4 hours) x 3 days, 8 mg/m²/dose (IV over 4 hours) x 3 days, 10 mg/m²/dose (IV over 4 hours) x 3 days.
- interventionNames
- Biological: hu14.18-IL2 fusion protein
Primary outcomes (1)
- measure
- Determine the MTD and pharmacokinetics of hu14.18-IL2 fusion protein
- description
- Determine the MTD of hu14.18-IL2 fusion protein and determine the pharmacokinetics of the fusion protein when given as I.V. injections
Secondary outcomes (1)
- measure
- Assess immunological changes associated with fusion protein therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed neuroblastoma or melanoma at original diagnosis * Refractory to chemotherapy or recurrence after prior multiagent chemotherapy * Measurable or evaluable (detectable by bone scan) metastatic disease OR * No evidence of disease if complete response to prior surgical resection, radiotherapy, and/or chemotherapy OR * Histologically confirmed tumor expressing GD2 antigen at original diagnosis or relapse * Refractory to standard treatment * Measurable or evaluable disease by clinical assessments or laboratory markers OR * No evidence of disease after prior surgical resection of metastatic, recurrent disease * Histologically confirmed recurrent osteogenic sarcoma after prior chemotherapy allowed * Soft tissue sarcoma allowed * No primary CNS tumors * Prior CNS metastases allowed, provided: * Disease previously treated * Disease clinically stable for 4 weeks before study * At least 4 weeks since prior steroids for CNS metastases * No clinically detectable pleural effusions or ascites PATIENT CHARACTERISTICS: Age: * 21 and under Performance status: * Karnofsky 60-100% for children over age 10 * Lansky 60-100% for children age 10 and under Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 (transfusion allowed) * Hemoglobin at least 9.0 g/dL (transfusion allowed) Hepatic: * Bilirubin less than 1.5 mg/dL * ALT or AST no greater than 2.5 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min Cardiovascular: * Shortening fraction at least 27% by echocardiogram OR * Ejection fraction more than 50% by MUGA scan * No congestive heart failure * No uncontrolled cardiac rhythm disturbance Pulmonary: * FEV\_1 and FVC more than 60% of predicted OR * No dyspnea at rest * No exercise intolerance * Oxygen saturation more than 94% by pulse oximetry on room air Neurologic: * No seizure disorders requiring antiseizure medications * No significant neurologic deficit or grade 2 or greater objective peripheral neuropathy Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No significant concurrent illnesses unrelated to cancer or its treatment * No significant psychiatric disabilities * No uncontrolled active infections * No uncontrolled active peptic ulcer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior growth factors * At least 1 week since prior immunomodulatory therapy * Prior monoclonal antibodies allowed if no detectable antibody to hu14.18 * Prior autologous bone marrow transplantation (BMT) or stem cell transplantation (SCT) allowed * Prior autologous BMT or SCT with monoclonal antibody-purged specimens allowed * No concurrent growth factors * No concurrent interferon Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or melphalan) * No concurrent palliative chemotherapy Endocrine therapy: * See Disease Characteristics * At least 2 weeks since prior glucocorticoids, except for life-threatening symptoms * No concurrent corticosteroids * No concurrent glucocorticoids, except for life-threatening symptoms Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy * No concurrent palliative radiotherapy Surgery: * See Disease Characteristics * At least 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy) * No prior organ allografts * No concurrent palliative surgery Other: * Recovered from prior therapy * At least 1 week since prior tretinoin * At least 3 weeks since prior immunosuppressive therapy * No other concurrent immunosuppressive drugs
References
Publications (1)
- RESULTOsenga KL, Hank JA, Albertini MR, Gan J, Sternberg AG, Eickhoff J, Seeger RC, Matthay KK, Reynolds CP, Twist C, Krailo M, Adamson PC, Reisfeld RA, Gillies SD, Sondel PM; Children's Oncology Group. A phase I clinical trial of the hu14.18-IL2 (EMD 273063) as a treatment for children with refractory or recurrent neuroblastoma and melanoma: a study of the Children's Oncology Group. Clin Cancer Res. 2006 Mar 15;12(6):1750-9. doi: 10.1158/1078-0432.CCR-05-2000. PMID 16551859