Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia (UPCC04407)

Abramson Cancer Center at Penn Medicine

Status and phase

Terminated

Phase 2

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Bexarotene

Study type

Interventional

Funder types

Other

Identifiers

NCT00615784

UPCC 04407

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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