Study of Bexarotene in Patients With Acute Myeloid Leukemia

NCT ID: NCT00316030

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

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.

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.

Conditions

AML; Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Bexarotene

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

University of Pennsylvania

Principal Investigators

Donald E Tsai, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Abramson Cancer Center of University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

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Other Identifiers

708935

Identifier Type: -

Identifier Source: secondary_id

UPCC 12403

Identifier Type: -

Identifier Source: org_study_id