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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Allopurinol; Asparaginase; BB 1101; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Lenograstim; Leucovorin; Liposomal doxorubicin; Mercaptopurine; Methotrexate; Mitoxantrone; Prednisone; Thioguanine; Trimethoprim, Sulfamethoxazole Drug Combination; Vincristine

Criteria

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