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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

Two months after 17th patient has started treatment with Bexarotene

Safety Issue:

Yes

Principal Investigator

Donald E. Tsai, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 04407

NCT ID:

NCT00615784

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • AML
  • Bexarotene
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Abramson Cancer Center Of University of PennsylvaniaPhiladelphia, Pennsylvania  19104