Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML)
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | March 2010 |
| End Date: | March 2019 |
| Contact: | Amanda Cashen, M.D. |
| Email: | acashen@dom.wustl.edu |
| Phone: | 314-454-8304 |
A Phase I Dose Escalation Study of Intravenous Decitabine in Combination With Oral Bexarotene in Patients With Acute Myeloid Leukemia
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.
Primary Objective:
- To determine the safety and tolerability of combination decitabine and bexarotene
during four cycles of therapy.
Secondary Objectives:
- To determine the complete remission (CR) and partial remission (PR) rate after four
cycles of therapy.
- To determine the rates of hematological improvement, transfusion independence, time to
progression, cytogenetic response, and survival.
- To perform correlative studies defining transcriptional response to bexarotene in
primary AML bone marrow cells.
- To perform correlative studies examining the clonality of morphologically
differentiated neutrophils by FISH in patients with improved neutrophil counts.
- To perform correlative studies comparing the self-renewal of morphologically
differentiated neutrophils and leukemic blasts by colony forming assays in patients
with improved neutrophil counts.
- To perform correlative studies of platelet function by PFA100 in patients with platelet
counts improved to >100,000/Microliter.
Inclusion Criteria:
- AML with bone marrow blasts ≥ 20%.
- Relapsed disease after 1 or more lines of prior salvage chemotherapy and any FAB-AML,
or
- Untreated 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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
Click here to add this to my saved trials
