NCT00877110|CompletedPhase 1DMC
Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
Phase I Study of Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · FDR004128
interventional
71
1 country
1
Study Start
April 2, 2009
Actual (reported)Primary Completion
January 7, 2019
Actual (reported)Study Completion
January 7, 2019
Actual (reported)Funding Source - FDA OOPD FDR004128 The goal of this study is to see if it is safe and feasible to give chemotherapy, natural killer (NK) cells, and an antibody called 3F8. The NK cells must come from a family member who shares half of the HLA proteins which are immune proteins important in transplant. NK cells are a type of white blood cell. They can recognize and kill abnormal cells in the body and can work together with antibodies to kill target cells. The antibody 3F8 specifically recognizes a protein present on the target cancer cell.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 7, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2009
Actual (reported)April 6, 2009
Actual (reported)April 7, 2009
Actual (reported)January 7, 2019
Actual (reported)January 7, 2019
Actual (reported)Assess the feasibility and safety of administering allogeneic haploidentical NK infusions with 3F8 in patients with high-risk NB
3 years
Estimate the anti-NB effect of allogeneic NK infusions plus 3F8
3 years
Assess the impact of KIR/HLA immunogenetics on disease response to NK/3F8
3 years
Assess the relationship between CD16 polymorphism and ADCC in vitro
This is a phase I study to assess the safety and feasibility of combining HLA-mismatched (KIR ligand incompatible) NK cells with 3F8 in high-risk NB patients. Following chemotherapy, patients will be treated in sequential groups of 3 patients/dose of NK cells. Four dose levels of NK cells, starting at dose level I, will be evaluated in this treatment protocol. In the unlikely case toxicity is encountered at dose level I, patients will then be treated at the lower dose level 0. Patients can receive up to 3 cycles of treatment on protocol. For subsequent cycles, patients will be treated at either less than or at the same dose level of NK cells as their first cycle.
Patients will receive combination chemotherapy with intravenous (IV) cyclophosphamide 70mg/kg/day (for patients with body weight\<70kg) or 2100mg/m2/day (for patients with body weight ≥70kg) for two days, IV vincristine 0.067mg/kg or 2mg/m2/day (lower of the two doses to be chosen; maximum 2mg) for one day, and IV topotecan 2.4 mg/m2/day for 3 days during their first cycle. If receiving a second and/or third cycle, the only chemotherapy patients will receive is cyclophosphamide at 50 mg/kg/day for 2 days. On Day 0, patients will receive a single dose of allogeneic NK cells isolated from a HLA-haploidentical related donor. On day +3, the patient will start daily infusion of 3F8 for 5 days. The treatment schedule may require minor adjustment by ±1 day as clinically indicated (e.g. due to PDH closure for holidays or due to inclement weather).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
cyclophosphamide, vincristine, topotecan ,allogeneic NK cells & 3F8
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMemorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Shakeel Modak, MD
Memorial Sloan Kettering Cancer Center
71 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2009
First Posted
April 7, 2009
Study Start
April 2, 2009
Actual (reported)Primary Completion
3 years
Contact the study team to confirm eligibility.
January 7, 2019
Actual (reported)Study Completion
January 7, 2019
Actual (reported)Last Updated
January 10, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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