Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.

Conditions

• Leukemia

Interventions

BIOLOGICAL

filgrastim

given subcutaneously (SC)

DRUG

cyclophosphamide

IV over 15-30 minutes

DRUG

cytarabine

IV over 3 hours twice daily

DRUG

daunorubicin hydrochloride

IV over 15 minutes

DRUG

dexamethasone

oral twice daily

DRUG

etoposide

IV over 1 hour

DRUG

leucovorin calcium

rescue IV over 24 hours

DRUG

mercaptopurine

oral

DRUG

methotrexate

intramuscularly (IM)

DRUG

pegaspargase

intramuscularly (IM)

DRUG

therapeutic hydrocortisone

DRUG

vincristine sulfate

given IV

RADIATION

radiation therapy

Patients with isolated testicular relapse will start Induction with a single dose of high-dose methotrexate (HDMTX) and will not receive either testicular or cranial radiation. Patients with isolated CNS relapse will NOT receive the initial dose of HDMTX prior to Induction, but will receive 1200 cGy of cranial radiation after completing the initial 12 months of intensive systemic chemotherapy.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Julio C. Barredo, MD · University of Miami Miller School of Medicine-Sylvester Cancer Center

• Caroline A. Hastings, MD · UCSF Benioff Children's Hospital Oakland

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Months

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-11-30

Primary Completion

2013-09-30

Countries

• United States
• Australia
• Canada
• New Zealand
• Switzerland

Study Locations