3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow
|ClinicalTrials.gov Identifier: NCT01183897|
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||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow: 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
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
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.
- Assess the activity of high-dose 3F8/GM-CSF [ Time Frame: 2 years ]against persistent neuroblastoma in bone marrow of patients who have no other evidence of disease by standard studies.
- Apply real-time quantitative RT-PCR [ Time Frame: 2 years ]to test the hypothesis that the minimal residual disease content of bone marrow after the first treatments with 3F8/GMCSF has significant prognostic impact on progression-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): NCT01183897
|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|