Study: NCT00439296

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-751
Description: Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-751
Description: Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-751
Description: Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-751
Description: Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-751
Description: Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-751
Description: Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: ABT-751
Description: Treatment Course 1:~Oral capsule to be given daily for 21 days at assigned dose.~Treatment Course 2:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 15-35.~Treatment Course 3:~ABT-751 will be taken once daily, by mouth, at the assigned dose on days 1-21 followed by 1 week of rest.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-asparaginase
Description: In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-asparaginase
Description: In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-asparaginase
Description: In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-asparaginase
Description: In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-asparaginase
Description: In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-asparaginase
Description: In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: PEG-asparaginase
Description: In Treatment Course 1:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on days 4, 11 and 18.~In Treatment Course 2:~* 2500 IU's/m2/day.~* Intramuscular injection (IM) on day 15.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin
Description: In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: * Given Intrathecally on day 1 of course 1 at the dose defined by age below.~  * 30 mg for patients age 1-1.99~ * 50 mg for patients age 2-2.99~ * 70 mg for patients \>3 years of age~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: * Given Intrathecally on day 1 of course 1 at the dose defined by age below.~  * 30 mg for patients age 1-1.99~ * 50 mg for patients age 2-2.99~ * 70 mg for patients \>3 years of age~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: * Given Intrathecally on day 1 of course 1 at the dose defined by age below.~  * 30 mg for patients age 1-1.99~ * 50 mg for patients age 2-2.99~ * 70 mg for patients \>3 years of age~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: * Given Intrathecally on day 1 of course 1 at the dose defined by age below.~  * 30 mg for patients age 1-1.99~ * 50 mg for patients age 2-2.99~ * 70 mg for patients \>3 years of age~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: * Given Intrathecally on day 1 of course 1 at the dose defined by age below.~  * 30 mg for patients age 1-1.99~ * 50 mg for patients age 2-2.99~ * 70 mg for patients \>3 years of age~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: * Given Intrathecally on day 1 of course 1 at the dose defined by age below.~  * 30 mg for patients age 1-1.99~ * 50 mg for patients age 2-2.99~ * 70 mg for patients \>3 years of age~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: * Given Intrathecally on day 1 of course 1 at the dose defined by age below.~  * 30 mg for patients age 1-1.99~ * 50 mg for patients age 2-2.99~ * 70 mg for patients \>3 years of age~* Omit IT Ara-C on Day 1 if patient received IT therapy prior to study enrollment as part of diagnostic lumbar puncture procedure.~In Treatment Course 2: • 75 mg/m2/day IV on days 2 through 5 and days 9 through 12.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: In Treatment Course 1:~• Given Intrathecally on day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: In Treatment Course 1:~• Given Intrathecally on day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: In Treatment Course 1:~• Given Intrathecally on day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: In Treatment Course 1:~• Given Intrathecally on day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: In Treatment Course 1:~• Given Intrathecally on day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: In Treatment Course 1:~• Given Intrathecally on day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: In Treatment Course 1:~• Given Intrathecally on day 15 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 2:~• Given Intrathecally on day 1, 8, 15 and 22 at the dose defined by age below.~* 8 mg for patients age 1-1.99~* 10 mg for patients age 2-2.99~* 12 mg for patients 3-8.99 years of age~* 15 mg for patients \>9 years of age~In Treatment Course 3:~Intrathecally on day 1 at the age-defined dose

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6-thioguanine
Description: Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6-thioguanine
Description: Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6-thioguanine
Description: Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6-thioguanine
Description: Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6-thioguanine
Description: Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6-thioguanine
Description: Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: 6-thioguanine
Description: Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.