Acute Myeloid Leukemia Clinical Trial

Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

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 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00615784

Recruitment Status:

Terminated

Sponsor:

Abramson Cancer Center of the University of Pennsylvania

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There is 1 Location for this study

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Abramson Cancer Center of University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT00615784

Recruitment Status:

Terminated

Sponsor:


Abramson Cancer Center of the University of Pennsylvania

How clear is this clinincal trial information?

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