Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00109837

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

Official Title:

A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy

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.

Eligibility

DISEASE CHARACTERISTICS:

* Morphologically confirmed acute lymphoblastic leukemia (ALL), meeting any of the following criteria:

* FAB class L1 or L2 disease
* Mixed lineage ALL
* Ph-negative/BCR/ABL-negative
* Newly diagnosed disease
* Patients with the following diagnoses are not eligible:

* FAB class L3 ALL
* Non-Hodgkin's lymphoma
* Chronic myelogenous leukemia in lymphoid blast crisis
* Mixed lineage acute myeloid leukemia
* Acute minimally differentiated myeloid leukemia (M0)
* Must be registered on protocols SWOG-9007 AND SWOG-S9910

PATIENT CHARACTERISTICS:

Age

* 18 to 64

Performance status

* Zubrod 0-3

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* No chronic liver disease
* Hepatitis panel, including hepatitis B and C, negative

* History of hepatitis A with positive antibody allowed

Renal

* Creatinine ≤ 1.5 times upper limit of normal OR
* Creatinine clearance > 60 mL/min

Cardiovascular

* Left ventricular function normal

* Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram
* No symptomatic congestive heart failure
* No coronary artery disease
* No cardiomyopathy
* No uncontrolled arrhythmia

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior remission induction chemotherapy for ALL

* Prior hydroxyurea to control WBC count allowed

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No other prior treatment for ALL

Disease(s) and\or Condition(s)

Leukemia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: filgrastim
    • Description: As needed per physician discretion
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: cyclophosphamide
    • Description: Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: cytarabine
    • Description: 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
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: daunorubicin
    • Description: Induction: 60 mg/m2/d; IV; days 1, 2, and 3
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: dexamethasone
    • Description: Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: doxorubicin
    • Description: Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type:
    • Name:
    • Description:
    • Arm Group Labels:
    • Type: DRUG
    • Name: mercaptopurine
    • Description: 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
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: methotrexate
    • Description: 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
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: mitoxantrone
    • Description: Induction 2: 80 mg/m2; IV; day 3
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: Asparaginase
    • Description: Induction: 2,000 IU/m2; IM or IV; day 15
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: prednisone
    • Description: Induction: 60 mg/m2/d; PO or IV; days 1-35
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: thioguanine
    • Description: Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: vincristine
    • Description: Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: RADIATION
    • Name: radiation therapy
    • Description: 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.
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: allopurinol
    • Description: 300 mg/d PO Days 1-7
    • Arm Group Labels: Induc x2, Consol, Maint
    • Type: DRUG
    • Name: bactrim
    • Description: 1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone
    • Arm Group Labels: Induc x2, Consol, Maint
Sponsor
  • SWOG Cancer Research Network