Status:
COMPLETED
Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, cytarabine, and idarubicin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than ...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose and/or biologically effective dose of arsenic trioxide followed by high-dose cytarabine and idarubicin in patients with previously untreated de novo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed de novo or secondary acute myeloid leukemia with ≥ 20% blasts AND at least 1 of the following characteristics\*:
- Auer rods
- Peroxidase or sudan black positive blasts
- Chloroacetate esterase-positive or diffusely non-specific esterase-positive blasts
- Presence of a myeloid immunophenotype by multiparameter flow cytometry, including expression of one or more myeloid markers (CD13, CD33) on blasts NOTE: \*Megakaryocytic leukemia can be diagnosed by the detection of platelet antigens (e.g. factor VIII, glycoprotein Ib or IIb/IIIa) using monoclonal antibodies or the presence of ultrastructural platelet peroxidase
- No acute promyelocytic leukemia
- No Philadelphia-chromosome positive chronic myeloid leukemia
- Prior hematologic disorders, including myelodysplastic syndromes, aplastic anemia, paroxysmal nocturnal hemoglobinuria, and myeloproliferative disorders allowed
- PATIENT CHARACTERISTICS:
- Age
- 18 to 59
- Performance status
- Not specified
- Life expectancy
- More than 4 weeks
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 2 times normal\*
- SGOT ≤ 2 times normal\*
- Alkaline phosphatase ≤ 2 times normal\* NOTE: \*Unless abnormalities are directly attributable to leukemia
- Renal
- Creatinine ≤ 1.5 times normal\* NOTE: \*Unless abnormalities are directly attributable to leukemia
- Cardiovascular
- Cardiac ejection fraction ≥ 45%\*
- Absolute QT interval ≤ 460 msec with potassium \> 4.0 mEq/L and magnesium \> 1.8 mg/dL
- No myocardial infarction within the past 6 months
- No uncontrolled symptomatic congestive heart failure
- No angina pectoris
- No multifocal cardiac arrythmias
- No other severe cardiovascular disease NOTE: \*Unless abnormalities are directly attributable to leukemia
- Other
- No serious medical or psychiatric illness that would preclude informed consent or limit survival to \< 4 weeks
- No uncontrolled diabetes mellitus
- No other concurrent active malignancy
- No known hypersensitivity to E. coli-derived drug preparations
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior chemotherapy for acute leukemia, except hydroxyurea to control white blood cell counts
- Prior chemotherapy for an antecedent malignancy or other medical condition allowed
- Endocrine therapy
- Not specified
- Radiotherapy
- Prior radiotherapy for an antecedent malignancy or other medical condition allowed
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00093483
Start Date
April 1 2002
End Date
December 1 2009
Last Update
January 13 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001