S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), and giving the drugs in different combinations may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

Conditions

• Leukemia

Interventions

BIOLOGICAL

filgrastim

As needed per physician discretion

DRUG

cyclophosphamide

Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1

DRUG

cytarabine

Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13

DRUG

daunorubicin

Induction: 60 mg/m2/d; IV; days 1, 2, and 3

DRUG

dexamethasone

Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28

DRUG

doxorubicin

Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22

DRUG

leucovorin

For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC \< 3,000

DRUG

mercaptopurine

Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs

DRUG

methotrexate

Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs

DRUG

mitoxantrone

Induction 2: 80 mg/m2; IV; day 3

DRUG

Asparaginase

Induction: 2,000 IU/m2; IM or IV; day 15

DRUG

prednisone

Induction: 60 mg/m2/d; PO or IV; days 1-35

DRUG

thioguanine

Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14

DRUG

vincristine

Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22

RADIATION

radiation therapy

For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.

DRUG

allopurinol

300 mg/d PO Days 1-7

DRUG

bactrim

1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Jerry Radich, MD · Fred Hutchinson Cancer Center

• Frederick R. Appelbaum, MD · Fred Hutchinson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-04-30

Primary Completion

2010-11-30

Completion

2014-11-30

Countries

• United States

Study Locations