CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 4 enrolled
Drug / intervention
3F8 monoclonal antibody and 13-cis-Retinoic Aciddrug
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/NCT01183416
NCT01183416Phase 2Completed
CompareCT.gov

High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation in Patients With High-Risk Neuroblastoma: A Phase II Study

Memorial Sloan Kettering Cancer Center·interventional·Posted Aug 17, 2010·Updated Oct 9, 2019

In Brief

A Phase 2 clinical trial evaluating 3F8 monoclonal antibody and 13-cis-Retinoic Acid for Neuroblastoma. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The purpose of this study is to see if high-dose 3F8 combined with GM-CSF is better than standard dose 3F8 in treating neuroblastoma. Another purpose of the study is to find out what effects, good and/or bad, 3F8 has on cancer. The investigators also want to see if the antibody works against a very small amount of neuroblastoma (minimal residual disease) that is left in the bone marrow.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2010
Enrollment StartAug 1, 2010
Primary CompletionOct 31, 2018
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 15.9 years ago

Interventions

3F8 monoclonal antibody and 13-cis-Retinoic Aciddrug

A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are \~6-8 weeks. 13-cis-retinoic acid is started after cycle 2.