Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

NCT00274807 | Completed Phase 2

• 3 other identifiers: CASE-CCF-4409P30CA043703CASE-CCF-0645
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leukemia

Keywords

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)

Interventions

filgrastim BIOLOGICAL

cytarabine DRUG

etoposide DRUG

mitoxantrone hydrochloride DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities

Interventions

Filgrastim; Cytarabine; Etoposide; Mitoxantrone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Anthraquinones; Anthrones; Anthracenes; Quinones

Study Officials

• Matt E. Kalaycio, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: June 1, 2001
• Primary Completion: April 1, 2007
• Study Completion: May 1, 2008
• Last Updated: February 11, 2011

Record last verified: 2011-02