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

Summary

This is a Phase I/II study of a drug called bortezomib given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). Bortezomib is a drug that has been approved by the Food and Drug Administration (FDA) for treating adults with multiple myeloma which is a type of blood cancer. Bortezomib has been shown to cause cancer cells to die in studies done on animals (mice). Studies have been done that have shown that some adults and children with cancer have shown a response to bortezomib when it is used alone. Studies have also been done in adults to evaluate the dose of bortezomib that can be safely given in combination with other chemotherapy drugs.

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

Sponsors & Collaborators

• Therapeutic Advances in Childhood Leukemia Consortium

  lead OTHER

Principal Investigators

• Yoav Messinger, MD · Children's Hospital and Clinics of Minnesota

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-08-04

Primary Completion

2011-02-26

Completion

2011-02-26

FDA Drug

Yes

Countries

• United States
• Australia
• Brazil
• Canada

Study Locations