Status:
COMPLETED
Azacitidine in Combination With Mitoxantrone, Etoposide Phosphate, and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Adult Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This phase I trial studies the side effects and best dose of azacitidine when given together with mitoxantrone, etoposide phosphate, and cytarabine in treating patients with acute myeloid leukemia tha...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose of azacitidine (5-azaC) when combined with mitoxantrone hydrochloride (mitoxantrone), etoposide phosphate (etoposide), and cytarabine (M...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) according to 2008 World Health Organization (WHO) classification; must have failed at least one cycle of induction chemotherapy or relapsed after achieving a complete remission following induction chemotherapy; patients with prior autologous or allogeneic stem cell transplant are permitted
- Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
- Life expectancy of greater than 6 months for any comorbid conditions
- Total bilirubin =\< 1.5 X institutional upper limit of normal
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
- Creatinine =\< 1.5 mg/dL
- Left ventricular ejection fraction \>= 40%
- Ability to understand and the willingness to sign a written informed consent document
- Patients must have recovered from the non-hematologic toxicity of prior therapy to less than grade 2
Exclusion
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patients receiving any other investigational agents or patients that have received any other investigational agents within 14 days of enrollment
- Patients with active central nervous system disease or with granulocytic sarcoma as sole site of disease
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, mannitol, or other agents used in study
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients with active infection are permitted to enroll provided that the infection is under control; myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities; prior to study entry, any echocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with azacitidine
- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Key Trial Info
Start Date :
January 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01249430
Start Date
January 20 2011
End Date
May 24 2013
Last Update
September 21 2017
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210