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AMLPhase 1NCT00316030

Study of Bexarotene in Patients With Acute Myeloid Leukemia

A Phase 1 study testing Bexarotene in people with AML and Acute Myeloid Leukemia, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML, Acute Myeloid Leukemia
What is being tested?
Bexarotene
How many people
54 participants
Where
1 siteUnited States
Study dates
Jan 2004to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.
  • Uncontrolled active infection
  • Known active CNS involvement with AML

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

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.

Read the detailed description

Despite recent advances in cancer treatment, the prognosis is still poor for patients with relapsed or chemotherapy resistant AML. Further aggressive chemotherapy can be attempted, but generally yields poor results. This clinical study is the first use of bexarotene in the treatment of patient with relapsed or chemotherapy resistant AML. The main purpose of the study is to identify the maximum safe dose of bexarotene in patient with AML. Another objective of the study is to explore the side effect profile of bexarotene in AML patients. The study is organized so that the initial patients will get a low dose of bexarotene to be taken daily. If these patients tolerate the drug, then later patients will get higher daily doses. Further groups of patients will continue to increase their dose of bexarotene until a maximum tolerated dose is identified. The stu dy will end at that point. Patients will take the drug daily by mouth until such a time that their AML is worsening or they are experiencing unacceptable side effects. Their participating will end at that point.

Being tested
Bexarotene
Keywords
AML, Acute Myeloid Leukemia, Bexarotene, Leukemia
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BexaroteneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

  2. To assess the toxicities of bexarotene in patients with AML

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2006 (estimated)
  2. Study startJan 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00316030
Sponsor's protocol ID
UPCC 12403
Other IDs
708935
Status last verified
Mar 2008
First submitted
17 Apr 2006
Last updated
8 Jun 2016
Results posted
No

Publications

  • 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.

    PubMed 8071941

  • 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.

    PubMed 7636877

  • 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.

    PubMed 8634447

  • 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.

    PubMed 9746784

  • 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.

    PubMed 12637463

  • 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.

    PubMed 14700480

  • 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.

    PubMed 11331325

  • 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.

    PubMed 10430065

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bexarotene in people with AML and Acute Myeloid Leukemia, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To identify the maximum tolerated daily dose of bexarotene in patients with Acute Myeloid Leukemia. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00316030, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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