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A Phase II Study Of hu14.18-IL2 In Children With Recurrent Or Refractory Neuroblastoma
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.
Details
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 39 |
| Start date | 2005-08 |
| Completion | 2012-05 |
Conditions
- Neuroblastoma
Interventions
- hu14.18-Interleukin-2 fusion protein
Primary outcomes
- Number of Responders (Response Rate) — Up to 30 weeks
Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.
Countries
United States, Canada