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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-05-31

Brief Summary

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The main objective is to determine the safety and tolerability of combination decitabine and bexarotene during four cycles of therapy.

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Detailed Description

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The investigators are seeking to study the combination of decitabine and bexarotene. These two agents have each shown efficacy in decreasing leukemic blast counts and restoring normal hematopoiesis via different mechanisms of action and with non-overlapping side-effect profiles. By combining these agents, the investigators hope to improve overall response rates. The investigators further hope to improve platelet and neutrophil counts in an even greater number of patients, thus treating two of the most important sources of morbidity and mortality in this patient population.

Conditions

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Leukemia, Myeloid, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Level 1

Decitabine 20 mg/m2 IV days 3-7 of cycle 1 and days 1-5 of subsequent cycles. Each cycle is 28 days.

Bexarotene 100 mg/m2 PO daily for each 28 day cycle.

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

Bexarotene

Intervention Type DRUG

Dose Level 2

Decitabine 20 mg/m2 IV days 3-7 of cycle 1 and days 1-5 of subsequent cycles. Each cycle is 28 days.

Bexarotene 200 mg/m2 PO daily for each 28 day cycle.

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

Bexarotene

Intervention Type DRUG

Dose Level 3

Decitabine 20 mg/m2 IV days 3-7 of cycle 1 and days 1-5 of subsequent cycles. Each cycle is 28 days.

Bexarotene 300 mg/m2 PO daily for each 28 day cycle.

Group Type EXPERIMENTAL

Decitabine

Intervention Type DRUG

Bexarotene

Intervention Type DRUG

Interventions

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Decitabine

Intervention Type DRUG

Bexarotene

Intervention Type DRUG

Other Intervention Names

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Dacogen® Targretin®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No