The purpose of this study is to find out whether an experimental drug called Hu3F8 can be given with the chemotherapy drugs irinotecan and temozolomide and another drug called GM-CSF. The investigators want to find out if this combination is safe and what effect it has on the participant and the disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
50mg/m\^2/day IV will be administered from day 1-5
(given concurrently with Irinotecan) 150mg/m\^2/day orally
2.25mg/kg IV will be administered on days 2, 4, 8 and 10
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The regimen will be considered safe if there are no toxicities requiring discontinuation of therapy in at least 9/10 patients during the first two cycles.
Time frame: 2 years
response rate (CR+PR)
Response assessment will be based on the best response over the course of four cycles. Disease response for NB will use the International NB Response Criteria. Patients who withdraw from the study prior to cycle 4 with \< partial response will also not be considered evaluable for response and will be replaced.
Time frame: 2 years
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250mcg/m2/day SC will be administered on days 6-10