Study: NCT00005596

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: daunorubicin hydrochloride
Description: 30 mg/m2 IV Day 1 of weeks 16, 17, and 18. Give Week 16 dose if ANC ≥ 500/μL and platelets ≥ 75,000/μL. Continue to give during Weeks 17 and 18, even in the face of uncomplicated myelosuppression

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: daunorubicin hydrochloride
Description: 30 mg/m2 IV Day 1 of weeks 16, 17, and 18. Give Week 16 dose if ANC ≥ 500/μL and platelets ≥ 75,000/μL. Continue to give during Weeks 17 and 18, even in the face of uncomplicated myelosuppression

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: 6 mg/m2/day divided BID for 7 days during weeks 8 and 17.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: 6 mg/m2/day divided BID for 7 days during weeks 8 and 17.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: 6 mg/m2/day divided BID for 7 days during weeks 8 and 17.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: dexamethasone
Description: 6 mg/m2/day divided BID for 7 days during weeks 8 and 17.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: 5 mg/m2/dose of leucovorin will be given PO q12h x 2 doses beginning 48 hours after the start of the MTX.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: 5 mg/m2/dose of leucovorin will be given PO q12h x 2 doses beginning 48 hours after the start of the MTX.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: 5 mg/m2/dose of leucovorin will be given PO q12h x 2 doses beginning 48 hours after the start of the MTX.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: leucovorin calcium
Description: 5 mg/m2/dose of leucovorin will be given PO q12h x 2 doses beginning 48 hours after the start of the MTX.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mercaptopurine
Description: 50 mg/m2 dose po qhs Weeks 5 through 13 (total 9 wks) and from Week 24 until the end of consolidation. Only hold for uncomplicated myelosuppression, only if IV MTX course is delayed, until ANC \> 500/μL and platelets \> 75,000/uL

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mercaptopurine
Description: 50 mg/m2 dose po qhs Weeks 5 through 13 (total 9 wks) and from Week 24 until the end of consolidation. Only hold for uncomplicated myelosuppression, only if IV MTX course is delayed, until ANC \> 500/μL and platelets \> 75,000/uL

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mercaptopurine
Description: 50 mg/m2 dose po qhs Weeks 5 through 13 (total 9 wks) and from Week 24 until the end of consolidation. Only hold for uncomplicated myelosuppression, only if IV MTX course is delayed, until ANC \> 500/μL and platelets \> 75,000/uL

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: mercaptopurine
Description: 50 mg/m2 dose po qhs Weeks 5 through 13 (total 9 wks) and from Week 24 until the end of consolidation. Only hold for uncomplicated myelosuppression, only if IV MTX course is delayed, until ANC \> 500/μL and platelets \> 75,000/uL

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methotrexate
Description: IV: 1 gm/m2 given as a 200 mg/m2 bolus over 20 min followed by 800 mg/m2 over 23.6 hours given during Weeks 7, 10, 13, 16, 19, and 22.~IT: Doses by age, Weeks 7, 10, 13, 16, 19 and 22.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methotrexate
Description: IV: 1 gm/m2 given as a 200 mg/m2 bolus over 20 min followed by 800 mg/m2 over 23.6 hours given during Weeks 7, 10, 13, 16, 19, and 22.~IT: Doses by age, Weeks 7, 10, 13, 16, 19 and 22.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methotrexate
Description: IV: 1 gm/m2 given as a 200 mg/m2 bolus over 20 min followed by 800 mg/m2 over 23.6 hours given during Weeks 7, 10, 13, 16, 19, and 22.~IT: Doses by age, Weeks 7, 10, 13, 16, 19 and 22.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: methotrexate
Description: IV: 1 gm/m2 given as a 200 mg/m2 bolus over 20 min followed by 800 mg/m2 over 23.6 hours given during Weeks 7, 10, 13, 16, 19, and 22.~IT: Doses by age, Weeks 7, 10, 13, 16, 19 and 22.