Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT ID: NCT00274807

Last Updated: 2011-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2008-05-31

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.

Conditions

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Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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filgrastim

Intervention Type BIOLOGICAL

cytarabine

Intervention Type DRUG

etoposide

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Fertile patients must use effective contraception
* No history of or active congestive heart failure

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cleveland Clinic Foundation

Principal Investigators

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Matt E. Kalaycio, MD

Role: STUDY_CHAIR

The Cleveland Clinic

Other Identifiers

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P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-CCF-4409

Identifier Type: -

Identifier Source: secondary_id

CASE-CCF-0645

Identifier Type: -

Identifier Source: secondary_id

CASE-CCF-4409

Identifier Type: -

Identifier Source: org_study_id

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