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Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

NCT ID: NCT00615784

Last Updated: 2020-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-25

Study Completion Date

2013-11-08

Brief Summary

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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

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Conditions

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Acute Myeloid Leukemia

Keywords

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Acute Myeloid Leukemia AML Bexarotene

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Bexarotene

Intervention Type DRUG

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

Interventions

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Bexarotene

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald E. Tsai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Abramson Cancer Center of University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UPCC 04407

Identifier Type: -

Identifier Source: secondary_id

UPCC 04407

Identifier Type: -

Identifier Source: org_study_id