CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
hu14.18-Interleukin-2 fusion proteinbiological
Likely dose
hu14.18-IL2 (interleukin-2 fusion protein) given intravenouslyAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed neuroblastoma that is relapsed or refractory to conventional therapy
  • ✓Age 21 years and under
  • ✓Measurable or evaluable disease by clinical, radiographic, histologic, MIBG scanning, or immunocytochemistry criteria
  • ✓Karnofsky ≥50% for children >16 years or Lansky ≥50% for children ≤16 years
Key exclusion· 8
  • ✕Symptomatic pleural effusions or ascites requiring constant or intermittent drainage
  • ✕Prior allogeneic bone marrow or stem cell transplantation
  • ✕Prior organ allografts
  • ✕Objective peripheral neuropathy ≥grade 2

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00082758
NCT00082758Phase 2Completed
CompareCT.gov

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

Children's Oncology Group·interventional·Posted May 19, 2004·Updated Feb 12, 2015

In Brief

A Phase 2 clinical trial evaluating hu14.18-Interleukin-2 fusion protein for Neuroblastoma. Completed, enrolled 39 participants across 81 sites in 2 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2004
Enrollment StartAug 1, 2005
Primary CompletionFeb 1, 2008
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 22.1 years ago

Interventions

hu14.18-Interleukin-2 fusion proteinbiological

Given IV