Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, 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) may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.

Detailed Description
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OBJECTIVES: Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide. Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia. OUTLINE: Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3, cytarabine IV continuously over 72 hours on days 1-3 and 8-10, and etoposide IV continuously over 72 hours on days 8-10. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 4 and continuing until blood counts recover. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Official Title
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Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia

Conditions
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Leukemia

Intervention / Treatment
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* Biological: filgrastim
* Drug: cytarabine
* Drug: etoposide
* Drug: mitoxantrone hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia Previously untreated disease Previous hydroxyurea and/or corticosteroids are acceptable No preexisting history of a hematologic disorder Myelodysplastic features allowed No acute leukemia secondary to previous therapy No leukemic meningitis PATIENT CHARACTERISTICS: Bilirubin < 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia) Creatinine < 2.0 mg/dL Pregnant or lactating patients are ineligible Fertile patients must use effective contraception No history of or active congestive heart failure PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: cytarabine|nan|
|Drug: etoposide|nan|
|Drug: mitoxantrone hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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untreated adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)