Status:
TERMINATED
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 chemo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 25 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00615784
Start Date
May 25 2010
End Date
November 8 2013
Last Update
December 17 2020
Active Locations (1)
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1
Abramson Cancer Center of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104