High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation
|ClinicalTrials.gov Identifier: NCT01183416|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2010
Last Update Posted : September 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: 3F8 monoclonal antibody and 13-cis-Retinoic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
U.S. FDA Resources
Experimental: 3F8 monoclonal antibody and 13-cis-Retinoic Acid
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. The patients are post-transplant and in 1st complete/very good partial remission (CR/VGPR),89 with no evidence of NB by standard studies, but are at high risk for relapse.
Drug: 3F8 monoclonal antibody and 13-cis-Retinoic Acid
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.
- Assess the impact of high-dose 3F8/GM-CSF on relapse-free survival [ Time Frame: 2 years ]in patients who are post-stem-cell transplantation and in first complete or very good partial remission, but at high risk of relapse.
- Apply real-time quantitative RT-PCR to test the hypothesis that the minimal residual disease content of bone marrow [ Time Frame: 2 years ]after the first treatments with 3F8/GMCSF has significant prognostic impact on relapse-free survival.
- Monitor safety of the high-dose antibody treatment [ Time Frame: 2 years ]to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183416
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Brian Kushner, MD||Memorial Sloan Kettering Cancer Center|