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

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

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.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.
Time Frame: Two months after 17th patient has started treatment with Bexarotene, for up to 1 year
Hematologic response will be assessed according to modified criteria of an international working group defined by Cheson et al, Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674
Two months after 17th patient has started treatment with Bexarotene, for up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy
Time Frame: Two months after 17th patient has started treatment with Bexarotene, up to 1 year.
A clinically significant result will be recorded if the patient's bone marrow blasts percentage decreased by 50% or more over pretreatment blast percentage.
Two months after 17th patient has started treatment with Bexarotene, up to 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Donald E. Tsai, MD, PhD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 8, 2013

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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