Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Sponsor

The Cleveland Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00274807

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: filgrastim Drug: cytarabine Drug: etoposide Drug: mitoxantrone hydrochloride	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia

Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

May 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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