Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia

NCT00615784 | Terminated Phase 2 Results

• 1 other identifier: UPCC 04407
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia; AML; Bexarotene

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Bone Marrow Response Rate of Bexarotene in Subjects With AML Unable/Unwilling to Receive Systemic Chemotherapy

  Two months after 17th patient has started treatment with Bexarotene, up to 1 year.

Study Arms (1)

A

EXPERIMENTAL

Drug: Bexarotene

Interventions

Bexarotene DRUG

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Harjeet Sembhi, research program director
• Organization: abramsoncc, University of Pennsylvania

harjeet.sembhi@pennmedicine.upenn.edu

215-220-9688

Study Officials

• Donald E. Tsai, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: May 25, 2010
• Primary Completion: October 1, 2013
• Study Completion: November 8, 2013
• Last Updated: December 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-11

Locations

US (1)