Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

Summary

This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.

Conditions

• Relapsed Acute Lymphoblastic Leukemia
• Allergy to PEG e.Coli Asparaginase
• Allergy to Native e.Coli Asparaginase

Interventions

DRUG

Erwinase

The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses. Erwinase will be administered as a 2-hour intravenous infusion.

DRUG

Vincristine

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

DRUG

Dexamethasone

10 mg/m2/day divided BID. Give by mouth days 1-14.

DRUG

Doxorubicin

60 mg/m2/day IV over 15 minutes on day 1

DRUG

Cytarabine

Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3 and older

DRUG

Methotrexate

Given Intrathecally to all patients who are CNS 1 or 2 at study entry. Dose defined by age. Given on day 15 8mg for age 1-1.99 10 mg for age 2-2.99 12 mg for age 3-8.99 15 mg for age 9 and older

DRUG

Triple Intrathecal Therapy

Methotrexate, Cytarabine and Hydrocortisone given Intrathecally on day 8, 15 and 22 for patients who are CNS 3 at study entry. Doses determined by age.

DRUG

Dexrazoxane

Due to the limited availability of Dexrazoxane (Zinecard®), treatment will be at the discretion of the treating physician. Dose should be 600 mg/m2 as a IV push immediately prior to anthracycline dose (the elapsed time from the beginning of the dexrazoxane dose to the end of the anthracycline infusion should be 30 minutes or less).

Sponsors & Collaborators

• Therapeutic Advances in Childhood Leukemia Consortium

  lead OTHER

Principal Investigators

• Heather Grossman, MD · Children's Hopital New York

• Paul Gaynon, MD · Children's Hospital Los Angeles

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-13

Primary Completion

2010-06-04

Completion

2010-06-04

FDA Drug

Yes

Countries

• United States

Study Locations