Overview

Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)

Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
0
Participant gender:
All
Summary
The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Treatments:
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.