Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NeuroTherapia, Inc.

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: mitoxantrone hydrochloride; Drug: etoposide; Drug: cytarabine; Biological: filgrastim

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00274807

CASE-CCF-0645

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CCF-4409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)