3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow
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|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.
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): 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|