CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
hu14.18-IL2 fusion protein +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01334515
NCT01334515Phase 2Completed

Feasibility/Phase II Study of hu14.18-IL2 Immunocytokine + GM-CSF and Isotretinoin in Patients With Relapsed or Refractory Neuroblastoma

Children's Oncology Group·interventional·Posted Apr 13, 2011·Updated Oct 21, 2019

In Brief

A Phase 2 clinical trial evaluating hu14.18-IL2 fusion protein, isotretinoin, and 2 other interventions for Recurrent Neuroblastoma. Completed, enrolled 52 participants across 76 sites in 2 countries.

Detailed Summary

This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 31, 2013
Study CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.2 years ago

Interventions

hu14.18-IL2 fusion proteinbiological

Given IV

isotretinoindrug

Given PO

sargramostimbiological

Given SC

laboratory biomarker analysisother

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