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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00615784
First received: February 1, 2008
Last updated: August 29, 2013
Last verified: August 2013
  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 2

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

Resource links provided by NLM:


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 ]

Enrollment: 24
Study Start Date: January 2008
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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 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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00615784     History of Changes
Other Study ID Numbers: UPCC 04407, UPCC 04407
Study First Received: February 1, 2008
Last Updated: August 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Acute Myeloid Leukemia
AML
Bexarotene

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

ClinicalTrials.gov processed this record on August 28, 2014