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Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00274807
First received: January 10, 2006
Last updated: February 9, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Leukemia
Biological: filgrastim
Drug: cytarabine
Drug: etoposide
Drug: mitoxantrone hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Enrollment: 40
Study Start Date: June 2001
Study Completion Date: May 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274807

Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Matt E. Kalaycio, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Matt Kalaycio, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00274807     History of Changes
Other Study ID Numbers: CASE-CCF-4409, P30CA043703, CASE-CCF-4409, CASE-CCF-0645
Study First Received: January 10, 2006
Last Updated: February 9, 2011
Health Authority: United States: Federal Government

Keywords provided by The Cleveland Clinic:
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Mitoxantrone
Analgesics
Antineoplastic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014