Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Leukemia Clinical Trial

Official title:

Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274807
• Other study ID #: CASE-CCF-4409
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2006
• Last updated: February 9, 2011
• Start date: June 2001
• Est. completion date: May 2008

Study information

• Verified date: February 2011
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Biological:
• filgrastim

Drug:
• cytarabine

• etoposide

• mitoxantrone hydrochloride

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)