Back to resultsStudy of Bexarotene in Patients With Acute Myeloid Leukemia
Primary Purpose
AML, Acute Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bexarotene
Sponsored by
About this trial
This is an interventional treatment trial for AML focused on measuring AML, Acute Myeloid Leukemia, Bexarotene, Leukemia
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
Sites / Locations
- Abramson Cancer Center of University of Pennsylvania
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00316030
First Posted
April 17, 2006
Last Updated
June 7, 2016
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00316030
Brief Title
Study of Bexarotene in Patients With Acute Myeloid Leukemia
Official Title
A Phase I Study of Bexarotene in Patients With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML, Acute Myeloid Leukemia
Keywords
AML, Acute Myeloid Leukemia, Bexarotene, Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Bexarotene
Primary Outcome Measure Information:
Title
To identify the maximum tolerated daily dose of bexarotene in patients with Acute Myeloid Leukemia
Title
To assess the toxicities of bexarotene in patients with AML
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald E Tsai, M.D., Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
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8071941
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Results Reference
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Study of Bexarotene in Patients With Acute Myeloid Leukemia
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