Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia or Advanced Lymphoblastic Non-Hodgkin's Lymphoma

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Dexrazoxane may lessen the side effects of chemotherapy.

PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without dexrazoxane and with or without high-dose methotrexate in patients with acute lymphoblastic leukemia or advanced lymphoblastic non-Hodgkin's lymphoma.

Conditions

• Cardiac Toxicity
• Leukemia
• Lymphoma

Interventions

DRUG

asparaginase

Given IV

DRUG

cytarabine

Given IV

DRUG

dexrazoxane hydrochloride

Given IV

DRUG

doxorubicin hydrochloride

Given IV

DRUG

leucovorin calcium

Given IV

DRUG

mercaptopurine

Given orally

DRUG

methotrexate

Given IV

DRUG

prednisone

Given orally

DRUG

therapeutic hydrocortisone

Given IT

DRUG

vincristine sulfate

Given IV

RADIATION

radiation therapy

Radiation to cranium

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Barbara L. Asselin, MD · James P. Wilmot Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1996-06-30

Primary Completion

2001-09-30

Completion

2004-10-31