Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia - Full Text View

Sponsored by:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00615784

Purpose

The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.

Condition	Intervention	Phase
Acute Myeloid Leukemia	Drug: Bexarotene	Phase II

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Bexarotene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

To estimate hematologic response rate of bexarotene monotherapy in subjects with relapsed/refractory AML or newly diagnosed AML who are unable to receive systemic chemotherapy. [ Time Frame: Two months after 17th patient has started treatment with Bexarotene ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To further explore the safety profile of bexarotene in subjects with AML [ Time Frame: Two months after 17th patient has started treatment with Bexarotene. ] [ Designated as safety issue: Yes ]
To estimate bone marrow response rate of bexarotene in subjects with AML unable/unwilling to receive systemic chemotherapy [ Time Frame: Two months after 17th patient has started treatment with Bexarotene. ] [ Designated as safety issue: Yes ]
To estimate the overall survival of subjects receiving bexarotene monotherapy for the treatment of advanced AML. [ Time Frame: One year following last patient entered on study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	17
Study Start Date:	January 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Bexarotene Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient

Eligibility

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

Criteria

Inclusion Criteria:

Age >= 18 years
Confirmed diagnosis of AML as proven by bone marrow biopsy
Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy
ECOG performance status of 0-2
Recovered from toxicities of prior chemotherapy

Exclusion Criteria:

History of pancreatitis
Active alcohol abuse
Taken bexarotene in the past
WBC > 10,000/uL at time of enrollment
Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Myelotarg
Significant organ disfunction: total bilirubin > 3x ULN, AST or ALT >3 x ULN, creatinine > 3 mg/dL, on blood pressure supporting medications or mechanical ventilation
Active participant in any other investigational treatment study for AML
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
Know history of HIV
Known active CNS involvement with AML
Women of childbearing potential or active breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615784

Contacts

Contact: Melissa Potuzak

215-662-7383

melissa.potuzak@uphs.upenn.edu

Locations

United States, Pennsylvania
Abramson Cancer Center of University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Potuzak 215-662-7383 melissa.potuzak@uphs.upenn.edu

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

Donald E. Tsai, MD, PhD

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania ( Donald Tsai, M.D. )
Study ID Numbers:	UPCC 04407, UPCC 04407
Study First Received:	February 1, 2008
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00615784
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Acute Myeloid Leukemia
AML
Bexarotene

Study placed in the following topic categories:

Leukemia
Bexarotene
Acute myelogenous leukemia

Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Anticarcinogenic Agents
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009