Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

— UPCC04407  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00615784
• Other study ID #: UPCC 04407
• Secondary ID: UPCC 04407
• Status: Terminated
• Phase: Phase 2
• Start date: May 25, 2010
• Est. completion date: November 8, 2013

Study information

• Verified date: November 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: November 8, 2013
• Est. primary completion date: October 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
United States	Abramson Cancer Center of University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic Response Rate of Bexarotene Monotherapy in Subjects With Relapsed/Refractory AML or Newly Diagnosed AML Who Are Unable to Receive Systemic Chemotherapy.	Hematologic response will be assessed according to modified criteria of an international working group defined by Cheson et al, Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674	Two months after 17th patient has started treatment with Bexarotene, for up to 1 year
Secondary	Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy	A clinically significant result will be recorded if the patient's bone marrow blasts percentage decreased by 50% or more over pretreatment blast percentage.	Two months after 17th patient has started treatment with Bexarotene, up to 1 year.