Combination Chemotherapy in Treating Patients With Untreated 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have untreated acute lymphoblastic leukemia.

Conditions

• Leukemia

Interventions

BIOLOGICAL

G-CSF

Courses I, II, IV, V: 5 ug/kg/d subQ injection Day 4 until ANC \> 5,000 uL after nadir: 7 day minimum for Courses I \& IV

DRUG

asparaginase

6000 U/sq m subQ or IM injection 2X/wk for 6 doses starting on Day 5: Courses I \& IV

DRUG

cyclophosphamide

1200 mg/sq m IV infusion over 15-30 min Day 1 Courses I \& IV (pts \< 60y/o) 1000 mg/sq m IV infusion over 15-30 min Day 1 Courses II \& V

DRUG

cytarabine

2000 mg/sq m IV infusion over 3 hrs Days 1,2, \& 3: Courses II \& V

DRUG

daunorubicin hydrochloride

80mg/sq m (pts\<60y/o)OR 60mg/sq m (pts =/\>60y/o) IV infusion over 5-10 min Days 1,2,\& 3: Courses I \& IV

DRUG

leucovorin calcium

Courses III \& VI: 25mg/sq m IV infusion Days 2, 9, and 16 5mg/sq m PO q 6 hr for 8 doses or until serum MTX \<0.05 uM after ea IV dose

DRUG

mercaptopurine

60mg/sq m/d PO every day Course VII

DRUG

methotrexate

15mg intrathecal Day 1 Courses II \& V 1000mg/sq m IV infusion over 3 hrs Days 1, 8, \& 15 and 25mg/sq m PO q 6hr x 4 doses after ea IV dose: Courses III \& VI.

DRUG

prednisone

60mg/sq m/day PO Days 1-21 (pts\<60y/o) OR Days 1-7 (pts \>/= 60y/o) Courses I \& IV and Days 1-5 of ea 4 cycle in Course VII

DRUG

vincristine sulfate

2 mg total IV infusion Days 1,8,15,\& 22 Courses I \& IV and Days 1, 8, \& 15 Courses III \& VI, and Day 1 of ea 4 wk cycle in Course VII

DRUG

Allopurinol

300mg PO q day Days 1-14 Course I

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Alliance for Clinical Trials in Oncology

  lead OTHER

Principal Investigators

• Wendy Stock, MD · University of Chicago

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1999-01-31

Primary Completion

2004-02-29

Completion

2010-01-31

Countries

• United States

Study Locations