Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

August 4, 2006

Primary Completion Date

February 26, 2011

Study Completion Date

February 26, 2011

Conditions
Acute Lymphoblastic Leukemia
Interventions
DRUG

Bortezomib

Intravenous on days 1, 4, 8 and 11. Dose assigned at study entry.

DRUG

Dexamethasone

10 mg/m2/day divided BID, oral administration for 14 days.

DRUG

PEG-asparaginase

2500 IU/m2/day, intramuscular injection on Days 2, 8, 15 and 22

DRUG

Doxorubicin

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"

DRUG

Methotrexate

"Given intrathecally to all patients who are CNS 1 at study entry 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"

DRUG

Vincristine

1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22.

DRUG

Triple IT Therapy

"Triple IT therapy will be given intrathecally on Day 8, 15, and 22 for patients who are CNS 2 and CNS 3 at study entry. Regimen/dosing as follows:~Methotrexate-~* \<2 years: 8 mg~* 2 - \<3 y: 10 mg~* 3 - \<9 y: 12 mg~* \>=9 y: 15 mg~Cytarabine:~* \<2 years: 16 mg~* 2 - \<3 y: 20 mg~* 3 - \<9 y: 24 mg~* \>=9 y: 30 mg~Hydrocortisone:~* \<2 years: 8 mg~* 2 - \<3 y: 10 mg~* 3 - \<9 y: 12 mg~* \>=9 y: 15 mg"

Trial Locations (24)

2031

Sydney Children's Hospital, Randwick

2145

The Children's Hospital at Westmead, Westmead

10016

New York University Medical Center, New York

10032

Children's Hospital New York-Presbyterian, New York

20010

Children's National Medical Center, Washington D.C.

21231

Johns Hopkins / Sydney Kimmel Cancer Center, Baltimore

28203

Levine Children's Hospital, Charlotte

30322

Children's Healthcare of Atlanta, Atlanta

33136

University of Miami Cancer Center, Miami

43205

Nationwide Children's Hospital, Columbus

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

84113

Primary Children's Hospital, Salt Lake City

90027

Childrens Hospital Los Angeles, Los Angeles

90806

Miller Children's Hospital, Long Beach

91010

City of Hope, Duarte

94618

Children's Hospital & Research Center Oakland, Oakland

98105

Seattle Children's Hospital, Seattle

94304-1812

Stanford University Medical Center, Palo Alto

94143-0106

UCSF School of Medicine, San Francisco

02215

Dana Farber Cancer Center, Boston

48109-0914

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

55404-4597

Childrens Hospital & Clinics of Minnesota, Minneapolis

04023-062

Universidade Federale de Sao Paulo/Hospital Sao Paulo, São Paulo

M5G1X8

Sick Kids, Toronto

All Listed Sponsors
lead

Therapeutic Advances in Childhood Leukemia Consortium

OTHER

NCT00440726 - Bortezomib With Chemotherapy for Relapsed Pediatric Acute Lymphoblastic Leukemia (ALL) | Biotech Hunter | Biotech Hunter