Overview
Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)
Status:
Completed
Completed
Trial end date:
2014-05-01
2014-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Washington University School of MedicineTreatments:
Azacitidine
Bexarotene
Decitabine
Criteria
Inclusion Criteria:- AML with bone marrow blasts ≥ 20%.
- Relapsed disease after 1 or more lines of prior salvage chemotherapy and any FAB-AML,
or
- Diagnosis of AML and age ≥ 60 and not a candidate for cytotoxic chemotherapy and any
FAB-AML except FAB-M3.
- Performance status ≤ 2.
- Age ≥ 18 years.
Exclusion Criteria:
- Peripheral white blood cell count (WBC) > 10,000/microliter.
- Total bilirubin > 1.5 x normal.
- AST/ALT > 2.5 x normal.
- Serum creatinine > 2 x normal.
- Fasting serum triglyceride > 1,000 mg/dL.
- Active or poorly controlled graft vs host disease (GVHD).
- Pregnant or nursing.
- Known CNS leukemia.
- History of positive HIV serology.
- History of positive Hepatitis C serology.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, congestive heart failure of NYHA class 3 or 4, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situation that would limit
compliance with study requirements.
- Chemotherapy within 21 days of enrollment.
- Radiation therapy within 14 days of enrollment.