CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoicbiological
Likely dose
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic 80 mg/m2from 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/NCT01183897
NCT01183897Phase 2Completed
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3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow: A Phase II Study

Memorial Sloan Kettering Cancer Center·interventional·Posted Aug 18, 2010·Updated Aug 13, 2019

In Brief

A Phase 2 clinical trial evaluating 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic for Neuroblastoma. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of this study is to see find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 18, 2010
Enrollment StartAug 12, 2010
Primary CompletionSep 25, 2018
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 15.9 years ago

Interventions

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoicbiological

This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles.Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles The patients have primary refractory BM disease. Protocol treatment is through 24 months. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started no later than after cycle 4 (i.e., after response is scored), but sooner if CR is achieved after cycles 1, 2, or 3, or if early HAMA develops.