Study: NCT01014767

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cisplatin
Description: Cycles 1 \& 2: 70 mg/m²/d IV over 6 hours on day 4

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Standard Arm, Cycle 1: 1 g/m\^2 IV over 1 hour on day 2 and 3~All Arms, Cycles 3 \& 5: 1 g/m\^2 IV over 1 hour on day 2 and 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Standard Arm, Cycle 1: 1 g/m\^2 IV over 1 hour on day 2 and 3~All Arms, Cycles 3 \& 5: 1 g/m\^2 IV over 1 hour on day 2 and 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Standard Arm, Cycle 1: 1 g/m\^2 IV over 1 hour on day 2 and 3~All Arms, Cycles 3 \& 5: 1 g/m\^2 IV over 1 hour on day 2 and 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Standard Arm, Cycle 1: 1 g/m\^2 IV over 1 hour on day 2 and 3~All Arms, Cycles 3 \& 5: 1 g/m\^2 IV over 1 hour on day 2 and 3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dactinomycin
Description: Cycles 1 \& 2: 45 µg/kg/day (max. 2 mg), IV on day 1

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: Cycles 1 \& 2: 25 mg/m²/day IV over 12 hrs on days 1-3

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Standard Arm (1), Cycles 1 \& 2:~100 mg/m2 IV over 1 hour on days 1-5~All Arms, Cycles 4-6:~100 mg/m2 IV over 1 hour on days 1-5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Standard Arm (1), Cycles 1 \& 2:~100 mg/m2 IV over 1 hour on days 1-5~All Arms, Cycles 4-6:~100 mg/m2 IV over 1 hour on days 1-5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Standard Arm (1), Cycles 1 \& 2:~100 mg/m2 IV over 1 hour on days 1-5~All Arms, Cycles 4-6:~100 mg/m2 IV over 1 hour on days 1-5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Etoposide
Description: Standard Arm (1), Cycles 1 \& 2:~100 mg/m2 IV over 1 hour on days 1-5~All Arms, Cycles 4-6:~100 mg/m2 IV over 1 hour on days 1-5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Irinotecan
Description: Temozolomide Irinotecan arm (4), Cycles 1 \& 2:~50 mg/m2/day x 5 days as 1 hour IV infusions

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin
Description: Given with Methotrexate as leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: 5g/m2 IV over 24 hours with leucovorin rescue at hour 42 given three times on days 1, 15 and 29.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Temozolomide
Description: 150 mg/m2/day x 5 days orally and combined with irinotecan 50 mg/m2/day IV x 5 days as one hour infusions.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Standard Arm (1), Cycles 1 \& 2 : 1.5 mg/m\^2 IV over 15 minutes on day 5~Doxorubicin/cisplatin arm (2), Cycles 1 \& 2: 1.5 mg/m\^2/day (max. 2 mg), i.v. on days 8, 15~For all Groups, Cycles 3 - 6: 1.5 mg/m2 IV over 15 minutes on day 5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Standard Arm (1), Cycles 1 \& 2 : 1.5 mg/m\^2 IV over 15 minutes on day 5~Doxorubicin/cisplatin arm (2), Cycles 1 \& 2: 1.5 mg/m\^2/day (max. 2 mg), i.v. on days 8, 15~For all Groups, Cycles 3 - 6: 1.5 mg/m2 IV over 15 minutes on day 5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Standard Arm (1), Cycles 1 \& 2 : 1.5 mg/m\^2 IV over 15 minutes on day 5~Doxorubicin/cisplatin arm (2), Cycles 1 \& 2: 1.5 mg/m\^2/day (max. 2 mg), i.v. on days 8, 15~For all Groups, Cycles 3 - 6: 1.5 mg/m2 IV over 15 minutes on day 5

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine
Description: Standard Arm (1), Cycles 1 \& 2 : 1.5 mg/m\^2 IV over 15 minutes on day 5~Doxorubicin/cisplatin arm (2), Cycles 1 \& 2: 1.5 mg/m\^2/day (max. 2 mg), i.v. on days 8, 15~For all Groups, Cycles 3 - 6: 1.5 mg/m2 IV over 15 minutes on day 5