Idarubicin and High-Dose Cytarabine in Treating Patients With Acute Myeloid Leukemia - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00528398

Purpose

RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, 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 giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cytarabine Drug: idarubicin	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cytarabine Cytarabine hydrochloride Idarubicin Idarubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial Utilizing Idarubicin in Combination With High Dose Ara-C for Induction Therapy for Adult Acute Myelogenous Leukemia (AML)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete remission (CR) rate [ Designated as safety issue: No ]

Estimated Enrollment:	195
Study Start Date:	March 1994
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the complete remission rate (CR), and compare this rate to the historical control group rate of 79% from our previous study achieved utilizing high-dose cytarabine and daunorubicin.
Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy, and compare this rate to the historical control group rate of 20%.
Determine the ability of patients treated with this regimen to receive further post-remission chemotherapy, and compare this rate to historical control group rate of 81% among 79 patients achieving CR in our previous study.
Further evaluate the toxicity of this regimen, and contrast this with our previous study results.
Determine the effect of prognostic variables on achieving a complete remission (e.g., age, WBC, FAB type, cytogenetics, and CD34).
Describe the CR rate, proportion of patients whose bone marrow is positive at day 7 post-induction chemotherapy, ability to receive further post-remission chemotherapy, and toxicity in 2 subgroups of patients (patients with prior myelodysplastic syndrome and patients with treatment-related leukemia).

OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with > 25% cellular biopsy or > 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

Newly diagnosed acute myeloid leukemia (AML)
- Morphologic proof (bone marrow aspirate smears or touch prep of marrow biopsy) of disease
- FAB M0, M1, M2, M4, M5a, M5b, M6a, M6b, and M7 disease
Previously untreated with radiotherapy or chemotherapy
- Patients with treatment-related leukemia are eligible even if they have received prior chemotherapy and radiotherapy
Patients with prior myelodysplastic syndrome are eligible
Extramedullary leukemia allowed
AML with lymphoid markers allowed

Exclusion criteria:

Blastic transformation of chronic myelogenous leukemia
Biphenotypic leukemia
FAB M3 disease (acute promyelocytic leukemia)

PATIENT CHARACTERISTICS:

Life expectancy ≥ 6 weeks
Total bilirubin < 1.5 g/dL
AST and ALT < 5 times upper limit of normal (ULN)
Creatinine < 1.5 mg/dL OR creatinine clearance > 70 mL/min
Ejection fraction ≥ 50% by MUGA unless decreased ejection fraction is secondary to leukemia infiltration
HIV antibody-negative

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

See Disease Characteristics
Prior hydroxyurea or corticosteroids allowed
At least 48 hours since prior and no concurrent itraconazole or fluconazole

Exclusion criteria:

More than 300 mg/m² of prior daunorubicin or equivalent dose of anthracycline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528398

Locations

United States, Arizona
Banner Good Samaritan Medical Center	Recruiting
Phoenix, Arizona, United States, 85006
Contact: Joseph Alvarnas, MD 602-239-4526 joseph.alvarnas@bannerhealth.com
United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Anthony S. Stein, MD

Beckman Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	City of Hope Comprehensive Cancer Center ( Anthony S. Stein )
Study ID Numbers:	CDR0000564537, CHNMC-93139, CHNMC-93139-94-03-1
Study First Received:	September 10, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00528398
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult erythroleukemia (M6a)

adult pure erythroid leukemia (M6b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia
untreated adult acute myeloid leukemia

Study placed in the following topic categories:

Leukemia, Monocytic, Acute
Acute myelogenous leukemia
Acute myelomonocytic leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Leukemia, Myelomonocytic, Acute
Leukemia
Idarubicin

Leukemia, Erythroblastic, Acute
Neoplasm Metastasis
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Congenital Abnormalities
Acute monoblastic leukemia
Acute myelocytic leukemia
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents

Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009