Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma

PHASE2CompletedINTERVENTIONAL
Enrollment

291

Participants

Timeline

Start Date

July 31, 2003

Primary Completion Date

January 15, 2021

Study Completion Date

January 15, 2021

Conditions
Neuroblastoma
Interventions
BIOLOGICAL

anti-GD2 murine IgG3 monoclonal antibody 3F8

The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over \~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started \~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive \~10 cycles.

BIOLOGICAL

anti-GD2 murine IgG3 monoclonal antibody 3F8

The total dosage of 3F8 per cycle is the same as in prior trials (100 mg/m2), administered at 20 mg/m2/day and infused over \~1.5 hr or less (0.5 hr is customary), with analgesics and antihistamines used as needed for expected side-effects. 3F8 is started \~1 hr after completion of GM-CSF administration. GM-CSF is dosed at 250 mcg/m2/day from day -5 to day +1 (Wednesday to Tuesday is customary) , and is 500 mcg/m2/day thereafter (i.e., on days +2 to +4; Wednesday to Friday), as in the predecessor protocol.18,74 Patients come off study if progressive disease occurs or if there is life-threatening grade 4 toxicity from 3F8; otherwise, patients will receive a minimum of 4 cycles of treatment and will continue treatment through 24 months. It is expected that patients will receive \~10 cycles.

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT00072358 - Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma | Biotech Hunter | Biotech Hunter