Study of Bexarotene in Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00316030
First received: April 17, 2006
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
AML
Acute Myeloid Leukemia
Drug: Bexarotene
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Bexarotene in Patients With Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 54
Study Start Date: January 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Uncontrolled active infection
  • Known active CNS involvement with AML
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316030

Locations
United States, Pennsylvania
Abramson Cancer Center of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Donald E Tsai, M.D., Ph.D. University of Pennsylvania
  More Information

Publications:

Responsible Party: Donald Tsai, M.D., University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00316030     History of Changes
Other Study ID Numbers: UPCC 12403, 708935
Study First Received: April 17, 2006
Last Updated: March 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
AML
Acute Myeloid Leukemia
Bexarotene
Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Bexarotene
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014