Status:
TERMINATED
Azacitidine, Mitoxantrone Hydrochloride, and Etoposide in Treating Older Patients With Poor-Prognosis Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Adult Acute Basophilic Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
This phase I trial studies the best dose of azacitidine and to see how well it works with mitoxantrone hydrochloride and etoposide in treating older patients with acute myeloid leukemia that has a low...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the highest tolerated dose of two dosing schedules of azacitidine when combined with mitoxantrone (mitoxantrone hydrochloride) and etoposide (A-NOVE) chemotherapy ...
Eligibility Criteria
Inclusion
- Acute myeloid leukemia (AML) as defined by World Health Organization (WHO) criteria, any subtype, de novo or secondary, except acute promyelocytic leukemia (APL)
- One of the following:
- Previously untreated, with adverse-risk cytogenetics, including any one of the following:
- Complete or partial deletion of chromosome 7
- Complete or partial deletion of chromosome 5
- At least 3 numerical or structural abnormalities, other than t(15;17), t(8;21) or inv(16) or variant
- 11q23 abnormalities
- Inv(3) or variant such as t(3:3)
- Previously untreated, transformed from prior myelodysplastic syndrome (MDS) or myeloproliferative disorder (MPD) other than CML
- Persistent leukemia following one cycle of 3+7 induction therapy (cytarabine plus either daunorubicin or idarubicin), any cytogenetic risk group
- Left ventricular ejection fraction (LVEF) \> 50% based on multi gated acquisition scan (MUGA) scan or 2-dimensional (2-D) echocardiogram
- Serum creatinine =\< 1.5 x upper limit of normal (ULN)
- Serum bilirubin =\< 1.5 x ULN
- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky \>= 60%)
- Patients with high initial white blood cell (WBC) should have the WBC reduced to below 50 x 10\^9/L with hydroxyurea, to minimize the risk of leukostasis related-complications; hydroxyurea is permitted up to 24 hours prior to starting azacitidine
- Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; men should not father a child while participating in this study
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Patients who have had chemotherapy, radiotherapy or investigational agents within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Patients who have received prior radiation greater than 3000 cGy to marrow producing areas
- Patients may not be receiving any other investigational agents
- Patients with active central nervous system (CNS) leukemia; prior CNS leukemia is permitted provided the cerebrospinal fluid has cleared and there is no other evidence of active CNS leukemia
- Prior therapy for AML with decitabine, azacitidine, mitoxantrone, or etoposide
- Prior therapy with azacitidine or decitabine for pre-existing MDS
- History of allergic reactions attributed to decitabine, azacitidine, etoposide, mitoxantrone, or compounds of similar chemical or biologic composition
- Uncontrolled intercurrent illness including, but not limited to, active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Human immunodeficiency virus (HIV)-positive patients with cluster of differentiation (CD) counts less than 500/mm\^3 and/or a history of HIV/acquired immune deficiency syndrome (AIDS)-related complications will be excluded from the study
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01260714
Start Date
December 1 2010
End Date
June 1 2015
Last Update
August 20 2015
Active Locations (2)
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1
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
2
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9