High-Dose 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of First Remission After Myeloablative Therapy and Autologous Stem-Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT01183416|
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : October 9, 2019
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: 3F8 monoclonal antibody and 13-cis-Retinoic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 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|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||October 31, 2018|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|