3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01183884|
Recruitment Status : Active, not recruiting
First Posted : August 18, 2010
Last Update Posted : September 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of 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/GM-CSF Immunotherapy Plus 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. 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 (20 mg/m2/day) for all cycles.
Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
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 (20 mg/m2/day) for all cycles. The patients are in > or = to 2nd CR/VGPR and at high risk for additional relapse. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 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 in second or greater complete or very good partial remission, but at high risk of additional 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): NCT01183884
|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|