Purpose

This phase II trial studies how well efatutazone dihydrochloride works in treating patients with previously treated myxoid liposarcoma that cannot be removed by surgery. Drugs used in chemotherapy, such as efatutazone dihydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


- Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1
representative hematoxylin and eosin (H&E) and 20 unstained myxoid liposarcoma tissue
slides available for submission to central pathology review; this review is mandatory
prior to registration to confirm eligibility

- Measurable disease

- Progression on at least one prior systemic chemotherapy for advanced, unresectable or
metastatic disease; prior adjuvant or neoadjuvant therapy is not included as prior
systemic chemotherapy unless treatment occurred within the 6 months prior to study
enrollment

- There is no limit to the number of prior lines of treatment a patient has
received

- No treatment with biologic therapy, immunotherapy, chemotherapy, investigational
agent for malignancy, or radiation =< 28 days before study registration; no
treatment with nitrosourea or mitomycin =< 42 days before study registration

- Patients should have resolution of any toxic effects of prior therapy (except
alopecia) to National Cancer Institute (NCI) Common Terminology Criteria for
Adverse Events (CTCAE), version 4.0, grade 1 or less

- No history of the following:

- Class III or IV congestive heart failure (CHF)

- Pericardial effusion =< 12 months (grade 3 or 4)

- Pericardial involvement with tumor

- Grade 2 or higher pleural effusion =< 6 months

- No symptomatic, untreated, or uncontrolled brain metastases present

- Not pregnant and not nursing; for women of childbearing potential only, a negative
pregnancy test done =< 7 days prior to registration is required; a female of
childbearing potential is a sexually mature female who:

- Has not undergone a hysterectomy or bilateral oophorectomy; or

- Has not been naturally postmenopausal for at least 12 consecutive months (i.e.,
has had menses at any time in the preceding 12 consecutive months)

- Patients with diabetes mellitus requiring concurrent treatment with insulin or
thiazolidinedione (TZD) oral agents are not eligible

- Patients with known hypersensitivity to any TZD oral agents are not eligible

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- Platelet count >= 75,000/mm^3

- Creatinine =< 1.5 mg/dL x upper limits of normal (ULN) OR calculated (calc.)
creatinine clearance >= 30 mL/min

- Bilirubin =< 1.5 x ULN; for subjects with liver metastases =< 3 x ULN is allowed

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x
ULN; for subjects with liver metastases, SGOT (AST) and SGPT (ALT) < 5 x the upper
normal limit of institution's normal range is allowed

- Eligible patients must have histopathologically confirmed myxoid liposarcoma with
confirmation of DDIT3 rearrangement

Study Design

Phase
Phase 2
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
efatutazone dihydrochloride
Patients receive efatutazone dihydrochloride PO BID continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Drug: efatutazone
    Given PO

Recruiting Locations

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Michael A. Caligiuri
800-293-5066
Jamesline@osumc.edu

More Details

NCT ID
NCT02249949
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

Michael Pishvaian, MD, PhD
202 444-2144

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the confirmed response rate for efatutazone dihydrochloride (efatutazone) in patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy.

SECONDARY OBJECTIVES:

I. To assess the progression free survival (PFS), overall survival (OS), and adverse event rates for efatutazone treated patients with advanced myxoid liposarcoma whose disease has progressed on at least one prior therapy.

TERTIARY OBJECTIVES:

I. To assess the predictive value of peroxisome proliferator-activated receptor (PPAR) and retinoid X receptors (RXR) tumor expression from archived patient tumor samples.

II. To assess the predictive value of the expression of PPARgamma-regulated markers of adipocytes differentiation.

III. To assess the predictive value of the expression of PPARgamma-regulated cell cycle proteins.

IV. To assess the effects of efatutazone treatment on serum adiponectin levels.

OUTLINE:

Patients receive efatutazone dihydrochloride orally (PO) twice daily (BID) continuously. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 12 weeks for 2 years and then every 6 months for up to 5 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.