Arsenic Trioxide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia

NCT00093483 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000387999P30CA016056RPCI-RP-0209
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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 one drug may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with cytarabine and idarubicin in treating patients with acute myeloid leukemia.

Conditions

Leukemia

Keywords

adult acute basophilic leukemia; adult acute eosinophilic leukemia; adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); 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 acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; untreated adult acute myeloid leukemia; secondary acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose and/or biologically effective dose or arsenic trioxide

  30 days after completion of study treatment

Interventions

filgrastim BIOLOGICAL

Subcutaneously beginning 12 hours after the last dose of chemotherapy and continuing until blood counts recover.

arsenic trioxide DRUG

IV over 1 hour on day 1

cytarabine DRUG

IV over 1 hour every 12 hours on days 1-6

idarubicin DRUG

IV over 30 minutes on days 2-4 (immediately after doses 3, 5 and 7 of cytarabine).

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Basophilic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Leukemia, Myelomonocytic, Acute; Congenital Abnormalities

Interventions

Filgrastim; Arsenic Trioxide; Cytarabine; Idarubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow 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; Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides

Study Officials

• Meir Wetzler, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: April 1, 2002
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

US (1)