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Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia

Intervention: Bexarotene (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Donald E. Tsai, MD, PhD, Principal Investigator, Affiliation: University of Pennsylvania

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.

Clinical Details

Official title: A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To estimate hematologic response rate of bexarotene monotherapy in subjects with relapsed/refractory AML or newly diagnosed AML who are unable to receive systemic chemotherapy.

Secondary outcome:

To further explore the safety profile of bexarotene in subjects with AML

To estimate bone marrow response rate of bexarotene in subjects with AML unable/unwilling to receive systemic chemotherapy

To estimate the overall survival of subjects receiving bexarotene monotherapy for the treatment of advanced AML.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: January 2008
Last updated: August 29, 2013

Page last updated: August 23, 2015

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