Supplemental File 1. Schema describing regimen DD4a as delivered on AREN0532
First dose of chemotherapy considered Day 1 Week 1.
Cycle 1 Cycle2 Cycle 3 Cycle 4
Week 1 2 3 Week 4 5 61 Week 7 8 9 Week 10 11 12¹ Evaluate.
Reporting period 1 ends at Week 12 (4 cycles)
A A
D+ D+
V V V V V V V V V V
RT² RT²
Cycle 5 Cycle 6 Cycle 7 Cycle 8 Cycle 9
Week 13 14 15 Week1 6
17 18 Week 19 20 21 Week 22 23 24 Week 25
A A A
D D
V* V* V* V* V*
RT2
Reporting period 2 ends at Week 28 – Evaluation - (5 cycles)
¹Perform surgical resection if the primary tumor was not resected at the time of diagnosis and the Week 6 or 12 imaging studies indicate that resection is feasible.
RT² – Radiation Therapy will begin at Week 1 for patients whose primary tumors were resected initially.
For patients with delayed tumor resection, radiation therapy should begin after the primary tumor is resected, usually at Week 7 or 13.
0.025 mg/kg/day IV for infants < 12 mo.
V Vincristine 0.05 mg/kg/day IV for children 12 mo – 3 yrs.
1.5 mg/m2/day IV for children ≥ 3 yrs.
Maximum dose: 2mg
V* Vincristine
0.034 mg mg/kg/day IV for infants < 12 mo.
0.067 mg/kg/day IV for children 12 mo – 3 yrs.
2 mg/m2/day IV for children ≥ 3 yrs.
Maximum dose: 2mg A
Dactinomycin
0.023 mg mg/kg/day IV for infants < 12 mo.
0.045 mg/kg/day IV for children ≥ 12 mo.
Maximum dose 2.3 mg.
D+ Doxorubicin 1.5 mg/kg/day IV for infants and children < 12 mo 45 mg/m2/day IV for children ≥12 mos.
D Doxorubicin 1 mg/kg/day IV for infants and children < 12 mo 30 mg/m2/day IV for children ≥12 mos.
±Doxorubicin and Dactinomycin dose should be reduced by 50% if doxorubicin or dactinomycin is given during or within 6 weeks of completing a course of whole abdomen XRT. The full doxorubicin or dactinomycin dose may be given it if coincides with the start of XRT
G-CSF (filgrastim) is not recommended for this regimen