ABT-751 With Chemotherapy for Relapsed Pediatric ALL

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

May 22, 2006

Primary Completion Date

May 19, 2009

Study Completion Date

September 23, 2009

Conditions
Recurrent Pediatric ALLRelapsed Pediatric ALLAcute Lymphoblastic LeukemiaRefractory Pediatric ALL
Interventions
DRUG

ABT-751

"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."

DRUG

Dexamethasone

"In Treatment Course 1 only:~* 10 mg/m2/day divided BID.~* Take dexamethasone by mouth days 1-14."

DRUG

PEG-asparaginase

"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."

DRUG

Doxorubicin

"In Treatment Course 1 only:~• 60 mg/m2/day IV over 15 minutes on day 1."

DRUG

Cytarabine

"* 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."

DRUG

Methotrexate

"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"

DRUG

Cyclophosphamide

Course 2 only: • 1000mg/m2/day IV over 30 minutes to be given on day 1.

DRUG

6-thioguanine

Treatment Course 2 only: • 60 mg/m2/day to be given orally on days 1 through 14.

Trial Locations (5)

90027

Childrens Hospital Los Angeles, Los Angeles

98105

Seattle Children's Hospital, Seattle

94304-1812

Stanford University Medical Center, Palo Alto

94143-0106

UCSF School of Medicine, San Francisco

48109-0914

C.S. Mott Children's Hospital, Ann Arbor

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER