ABT-751 With Chemotherapy for Relapsed Pediatric ALL

Summary

This is a phase I/II study of an investigational drug called ABT-751, produced by Abbott Laboratories, given in combination with chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) that has come back (recurred). The phase I portion of this study is being done to find the highest dose of ABT-751 that can be given safely in combination with other chemotherapy drugs. A safe dose is one that does not result in unacceptable side effects. After a safe dose for ABT-751 given with chemotherapy has been found, the study will add additional patients to find out if ABT-751 (given at the maximal safe dose) when given with additional chemotherapy is an effective therapy for the treatment of children with relapsed ALL. It is expected that approximately 15-35 children and young adults will take part in this study.

Conditions

• Recurrent Pediatric ALL
• Relapsed Pediatric ALL
• Acute Lymphoblastic Leukemia
• Refractory 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.

Sponsors & Collaborators

• Abbott

  collaborator INDUSTRY

• Therapeutic Advances in Childhood Leukemia Consortium

  lead OTHER

Principal Investigators

• Paul S Gaynon, MD · Childrens Hospital Los Angeles, Therapeutic Advances in Childhood Leukemia Consortium

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-22

Primary Completion

2009-05-19

Completion

2009-09-23

FDA Drug

Yes

Countries

• United States

Study Locations