Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia (UPCC 04407)

This study is currently recruiting participants.

Verified December 2011 by University of Pennsylvania

Sponsor:

Information provided by (Responsible Party):

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT00615784

First received: February 1, 2008

Last updated: February 6, 2013

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 1, 2008

Last Updated Date

February 6, 2013

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00615784 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Official Title ^ICMJE

A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myeloid Leukemia

Intervention ^ICMJE

Drug: Bexarotene

Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient

Study Arm (s)

Experimental: A

Intervention: Drug: Bexarotene

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 Mylotarg
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
Known history of HIV
Known active CNS involvement with AML
Women of childbearing potential or active breast feeding

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Brenda Horn

215-614-1812

brenda.horn@uphs.upenn.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00615784

Other Study ID Numbers ^ICMJE

UPCC 04407, UPCC 04407

Has Data Monitoring Committee

Responsible Party

University of Pennsylvania

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Donald E. Tsai, MD, PhD

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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