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Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
This study has been completed.
Study NCT00005795   Information provided by National Cancer Institute (NCI)
First Received: June 2, 2000   Last Updated: July 7, 2009   History of Changes

June 2, 2000
July 7, 2009
February 2000
 
 
 
Complete list of historical versions of study NCT00005795 on ClinicalTrials.gov Archive Site
 
 
 
Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Acute Myeloid Leukemia, Secondary Leukemia, and/or Newly-Diagnosed Patients Greater Than or Equal to 65 Years Old

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have acute myeloid leukemia.

OBJECTIVES: I. Determine the rate of response (complete or partial remission), duration of response, relapse free survival, and overall survival of patients with relapsed or refractory acute myeloid leukemia (AML) or untreated older patients or those with secondary AML when treated with arsenic trioxide. II. Evaluate the toxicities of this agent in this patient population. III. Measure degree of apoptosis induced and/or differentiation in pretreatment and posttreatment AML cells.

OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for up to 60 days, or until bone marrow blasts are less than 5%, followed by 4-6 weeks of rest. After the first course, additional courses of arsenic trioxide last 25 days. Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 1 additional 25 day course after achieving CR. Patients are followed monthly for 6 months, every 2 months for 6 months, every 3 months for 12 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.

Phase II
Interventional
Treatment
Leukemia
Drug: arsenic trioxide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS: Documented acute myelogenous leukemia (AML) including secondary AML and biphenotypic leukemia Secondary AML may be either chemotherapy induced or evolving from a myelodysplastic syndrome Bone marrow evidence of AML must include the following: Cellularity of 20% or greater Minimum of 20% leukemic cells Signs of bone marrow failure such as: Anemia (hemoglobin less than 12.0 g/dL) Granulocytopenia (granulocyte count less than 1,500/mm3) Thrombocytopenia (platelet count less than 100,000/mm3) Must not be any of the following: Acute lymphoblastic leukemia Blastic phase of chronic myelogenous leukemia Acute promyelocytic leukemia (M3) Prior induction therapy using any conventional induction chemotherapy regimen required In first or second relapse after successful induction therapy OR Failed 1 attempt at reinduction relapse OR Refractory to at least 1 prior induction therapy No prior induction therapy allowed in secondary AML or in newly diagnosed AML in patients at least 65 years old

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: See Disease Characteristics No evidence of being platelet transfusion refractory WBC no greater than 20,000/mm3 (leukapheresis, hydroxyurea, or both allowed) Hepatic: Bilirubin no greater than 2.0 mg/dL unless leukemic infiltration to liver SGOT or SGPT less than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No evidence of symptomatic coronary atherosclerotic heart disease Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active infection and afebrile Afebrile, stable, and completing antibiotics allowed Febrile not from infection but from blood products allowed

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent bone marrow transplantation Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent antileukemic agents

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00005795
 
CDR0000067756, NU-99H6, NU-476-016, NCI-T99-0094
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Study Chair: Martin S. Tallman, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP