Combination Chemotherapy in Treating Children With Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of chemotherapy is more effective for acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is comparing four regimens of combination chemotherapy to see how well they work in treating children with newly diagnosed acute lymphoblastic leukemia.

Conditions

• Leukemia

Interventions

DRUG

cyclophosphamide

DRUG

cytarabine

DRUG

daunorubicin hydrochloride

30 mg/m2 IV Day 1 of weeks 16, 17, and 18. Give Week 16 dose if ANC ≥ 500/μL and platelets ≥ 75,000/μL. Continue to give during Weeks 17 and 18, even in the face of uncomplicated myelosuppression

DRUG

dexamethasone

6 mg/m2/day divided BID for 7 days during weeks 8 and 17.

DRUG

leucovorin calcium

5 mg/m2/dose of leucovorin will be given PO q12h x 2 doses beginning 48 hours after the start of the MTX.

DRUG

mercaptopurine

50 mg/m2 dose po qhs Weeks 5 through 13 (total 9 wks) and from Week 24 until the end of consolidation. Only hold for uncomplicated myelosuppression, only if IV MTX course is delayed, until ANC \> 500/μL and platelets \> 75,000/uL

DRUG

methotrexate

IV: 1 gm/m2 given as a 200 mg/m2 bolus over 20 min followed by 800 mg/m2 over 23.6 hours given during Weeks 7, 10, 13, 16, 19, and 22. IT: Doses by age, Weeks 7, 10, 13, 16, 19 and 22.

DRUG

pegaspargase

2,500 IU/m2 will be given IM x 1 on Days 2,3,or 4 of Week 16; \> or = 1 day after the IT MTX

DRUG

thioguanine

60 mg/m2 po qhs during Weeks 20 and 21 (total 14 days). Start week 20 when ANC \> or = 500/ul and platelets \> or = 75,000/uL. Continue to give all 14 doses despite uncomplicated myelosuppression.

DRUG

vincristine sulfate

1.5 mg/m2 IV on Day 1 of Weeks 8, 9, 17 and 18 (max 2 mg)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Naomi J. Winick, MD · Simmons Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-04-30

Primary Completion

2005-07-31

Completion

2007-07-31

Countries

• United States
• Australia
• Canada
• Netherlands
• Puerto Rico
• Switzerland

Study Locations