Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
Status: | Recruiting |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/30/-0001 |
Start Date: | January 2008 |
Contact: | Brenda Horn |
Email: | brenda.horn@uphs.upenn.edu |
Phone: | 215-614-1812 |
A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class
drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant
to standard chemotherapy or are otherwise not eligible for conventional chemotherapy.
Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects
within normal and malignant cells that affect cell growth and cell death.
Inclusion Criteria:
- Age >= 18 years
- Confirmed diagnosis of AML as proven by bone marrow biopsy
- Must have received prior induction therapy with conventional chemotherapy and/or
Mylotarg or otherwise not eligible for conventional chemotherapy
- ECOG performance status of 0-2
- Recovered from toxicities of prior chemotherapy
Exclusion Criteria:
- History of pancreatitis
- Active alcohol abuse
- Taken bexarotene in the past
- WBC > 10,000/uL at time of enrollment
- Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or
low dose Mylotarg
- Significant organ disfunction: total bilirubin > 3x ULN, AST or ALT >3 x ULN,
creatinine > 3 mg/dL, on blood pressure supporting medications or mechanical
ventilation
- Active participant in any other investigational treatment study for AML
- Life expectancy of less than 1 month
- Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega)
within 1 week prior to treatment initiation
- Uncontrolled hyperlipidemia
- Known history of HIV
- Known active CNS involvement with AML
- Women of childbearing potential or active breast feeding
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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