NCT00316030

Brief Summary

Bexarotene may be useful in the treatment of Acute Myeloid Leukemia (AML). This is the first study on the use of bexarotene to treat patients with AML. The main purpose of this study is to establish the proper dose of bexarotene when used to treat AML. The side effect profile of bexarotene in patients with AML will also be explored.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
Last Updated

June 8, 2016

Status Verified

March 1, 2008

First QC Date

April 17, 2006

Last Update Submit

June 7, 2016

Conditions

AMLAcute Myeloid Leukemia

Keywords

AMLAcute Myeloid LeukemiaBexaroteneLeukemia

Outcome Measures

Primary Outcomes (2)

  • To identify the maximum tolerated daily dose of bexarotene in patients with Acute Myeloid Leukemia

  • To assess the toxicities of bexarotene in patients with AML

Interventions

BexaroteneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years.
  • Must have a histologically confirmed diagnosis of non-M3 AML as proven by bone marrow biopsy. Patients with CML in myeloid blast crisis are eligible.
  • Willing and able to give informed consent.
  • Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not be eligible for conventional chemotherapy
  • ECOG performance status of 0-2
  • Must have recovered from the toxicities of prior chemotherapy.
  • Women of childbearing potential must use effective contraception after enrollment in this study and have a negative pregnancy test within 1 week of study enrollment. They must continue to use effective contraception for 3 months after stopping bexarotene.
  • Men must agree to use effective methods of contraception while taking bexarotene and for 3 months after stopping therapy.

You may not qualify if:

  • History of pancreatitis.
  • Active alcohol abuse
  • Taken bexarotene in the past.
  • WBC \>10,000/uL at the time of enrollment. Patients may be taking hydrea for WBC control at the time of enrollment.
  • Cytotoxic chemotherapy or Mylotarg within the past 7 days other than hydrea.
  • Significant organ dysfunction: total bilirubin\>3x ULN, AST or ALT\>3x ULN, creatinine\>4mg/dL, on blood pressure supporting medications or mechanical ventilation.
  • Serious medical or psychiatric conditions that may compromise the safety of the patient while participating in this study.
  • Women of childbearing potential who are pregnant or actively breast feeding.
  • Active participant in any other investigational treatment study for their AML.
  • Unable/unwilling to perform required follow-up.
  • 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 (triglycerides\>1000 while on treatment with triglyceride lowering medications).
  • History of myeloablative allogeneic stem cell transplant.
  • Known history of HIV.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (8)

  • Boehm MF, Zhang L, Badea BA, White SK, Mais DE, Berger E, Suto CM, Goldman ME, Heyman RA. Synthesis and structure-activity relationships of novel retinoid X receptor-selective retinoids. J Med Chem. 1994 Sep 2;37(18):2930-41. doi: 10.1021/jm00044a014.

    PMID: 8071941BACKGROUND

  • Boehm MF, Zhang L, Zhi L, McClurg MR, Berger E, Wagoner M, Mais DE, Suto CM, Davies JA, Heyman RA, et al. Design and synthesis of potent retinoid X receptor selective ligands that induce apoptosis in leukemia cells. J Med Chem. 1995 Aug 4;38(16):3146-55. doi: 10.1021/jm00016a018.

    PMID: 7636877BACKGROUND

  • Kizaki M, Dawson MI, Heyman R, Elster E, Morosetti R, Pakkala S, Chen DL, Ueno H, Chao W, Morikawa M, Ikeda Y, Heber D, Pfahl M, Koeffler HP. Effects of novel retinoid X receptor-selective ligands on myeloid leukemia differentiation and proliferation in vitro. Blood. 1996 Mar 1;87(5):1977-84.

    PMID: 8634447BACKGROUND

  • Asou H, Koike M, Elstner E, Cambell M, Le J, Uskokovic MR, Kamada N, Koeffler HP. 19-nor vitamin-D analogs: a new class of potent inhibitors of proliferation and inducers of differentiation of human myeloid leukemia cell lines. Blood. 1998 Oct 1;92(7):2441-9.

    PMID: 9746784BACKGROUND

  • Esteva FJ, Glaspy J, Baidas S, Laufman L, Hutchins L, Dickler M, Tripathy D, Cohen R, DeMichele A, Yocum RC, Osborne CK, Hayes DF, Hortobagyi GN, Winer E, Demetri GD. Multicenter phase II study of oral bexarotene for patients with metastatic breast cancer. J Clin Oncol. 2003 Mar 15;21(6):999-1006. doi: 10.1200/JCO.2003.05.068.

    PMID: 12637463BACKGROUND

  • Rizvi N, Hawkins MJ, Eisenberg PD, Yocum RC, Reich SD; Ligand L1069-20 Working Group. Placebo-controlled trial of bexarotene, a retinoid x receptor agonist, as maintenance therapy for patients treated with chemotherapy for advanced non-small-cell lung cancer. Clin Lung Cancer. 2001 Feb;2(3):210-5. doi: 10.3816/clc.2001.n.005.

    PMID: 14700480BACKGROUND

  • Duvic M, Hymes K, Heald P, Breneman D, Martin AG, Myskowski P, Crowley C, Yocum RC; Bexarotene Worldwide Study Group. Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II-III trial results. J Clin Oncol. 2001 May 1;19(9):2456-71. doi: 10.1200/JCO.2001.19.9.2456.

    PMID: 11331325BACKGROUND

  • Rizvi NA, Marshall JL, Dahut W, Ness E, Truglia JA, Loewen G, Gill GM, Ulm EH, Geiser R, Jaunakais D, Hawkins MJ. A Phase I study of LGD1069 in adults with advanced cancer. Clin Cancer Res. 1999 Jul;5(7):1658-64.

    PMID: 10430065BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

TetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Donald E Tsai, M.D., Ph.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2006

First Posted

April 19, 2006

Study Start

January 1, 2004

Last Updated

June 8, 2016

Record last verified: 2008-03

Locations

US(1)