ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00615784
Recruitment Status : Active, not recruiting
First Posted : February 14, 2008
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Bexarotene Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia
Study Start Date : January 2008
Actual Primary Completion Date : October 2013


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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To further explore the safety profile of bexarotene in subjects with AML [ Time Frame: Two months after 17th patient has started treatment with Bexarotene. ]
  2. 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. ]
  3. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615784


Locations
United States, Pennsylvania
Abramson Cancer Center of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Donald E. Tsai, MD, PhD University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00615784     History of Changes
Other Study ID Numbers: UPCC 04407
UPCC 04407
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Acute Myeloid Leukemia
AML
Bexarotene

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Bexarotene
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents